BD Q-SYTE¿ LUER ACCESS SITE WITH 6 IN.BORE EXTENSION SET.
Report
- Report Number
- 9610847-2018-00132
- Event Type
- Malfunction
- Date Received
- May 8, 2018
- Date of Event
- April 20, 2018
- Report Date
- August 23, 2018
- Manufacturer
- BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 30382903851011
- PMA / PMN Number
- K142527
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: DEVICE RETURNED TO MANUFACTURE: YES.
INVESTIGATION SUMMARY: DEVICE/BATCH HISTORY RECORD REVIEW: 7143636 THIS LOT NUMBER WAS BUILT ON QFA LINE 2, STARTING ON JUNE 1, 2017 THROUGH JUNE 2, 2017. 7131928 THIS LOT NUMBER WAS BUILT ON QFA LINE 4, STARTING ON MAY 19, 2017 THROUGH MAY 21, 2017. REVIEW OF THE DHRS REVEALED ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. QN / SAP DATABASE REVIEW: NO. REASON: REVIEW IS NOT REQUIRED FOR LEVEL A INVESTIGATIONS AS PER MS-QS-083. FINDINGS: N/A. THE PEURA (END USER RISK ANALYSIS): YES. REASON: THE PEURA IS REQUIRED FOR ALL MDR REPORTABLE INVESTIGATIONS. FINDINGS: RM5699 REV 5 VERSION D WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. VISUAL ANALYSIS: OBSERVATIONS AND TESTING: RECEIVED ONE BD Q-SYTE WITH AN EXTENSION SET WITHIN AN OPEN PACKAGE FROM LOT NUMBER 7178882 REF # 385101 . VISUAL/MICROSCOPIC EXAMINATION: OBSERVED TRACES OF PATIENT RESIDUE ON THE TOP DISK OF THE Q-SYTE. OBSERVED THE SLIT OF THE QSYTE TOP DISK WAS DAMAGED (TEARS). OBSERVED THE TOP DISK OF THE SEPTUM WAS PUSHED INTO THE ADAPTER. RESIDUAL SEPTUM MATERIAL AND ADHESIVE WAS OBSERVED ON THE RIM OF THE Q-SYTE TOP BODY. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: NO. THE Q-SYTE UNIT DISPLAYED THE SEPTUM PUSHED INTO THE Q-SYTE TOP BODY. INVESTIGATION CONCLUSION: ROOT CAUSE IS INDETERMINATE. THE EVALUATION ON THE RIM OF THE Q-SYTE ADAPTER REVEALED EVIDENCE OF ADHESIVE AND SEPTUM DEPOSITS. THIS IS AN INDICATION THAT A BOND WAS PROVIDED DURING THE MANUFACTURING PROCESS. A FAILURE MODE ASSOCIATED WITH THE RETURNED SAMPLE DID NOT INDICATE THAT MANUFACTURING PROCESS INTRODUCED THE DAMAGE OBSERVED. EXTERNAL FORCES MOST LIKELY CONTRIBUTED TO THE DAMAGE OBSERVED. COMMENT: AN INSTRUCTION PAMPHLET IS PROVIDED WITH Q-SYTE PRODUCT. THIS INFORMATION DOCUMENTS THE POTENTIAL FAILURE MODES OF THIS DEVICE IF NOT USED PROPERLY.
IT WAS REPORTED WITH THE USE OF THE BD Q-SYTE¿ LUER ACCESS SITE WITH 6 IN. STANDARD BORE EXTENSION SET THERE WAS AN ISSUE WITH ABNORMAL/DEFORMED APPEARANCE OF THE DEVICE. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
IT WAS REPORTED WITH THE USE OF THE BD Q-SYTE¿ LUER ACCESS SITE WITH 6 IN. STANDARD BORE EXTENSION SET THERE WAS AN ISSUE WITH ABNORMAL/DEFORMED APPEARANCE OF THE DEVICE. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WITH THE USE OF THE BD Q-SYTE¿ LUER ACCESS SITE WITH 6 IN. STANDARD BORE EXTENSION SET THERE WAS AN ISSUE WITH ABNORMAL/DEFORMED APPEARANCE OF THE DEVICE. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 336048 | BD Q-SYTE¿ LUER ACCESS SITE WITH 6 IN.BORE EXTENSION SET. | Q-SYTE SPLIT SEPTUM | FPA | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. | 7178882 | 30382903851011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |