20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC
Report
- Report Number
- 1710034-2019-00765
- Event Type
- Malfunction
- Date Received
- July 12, 2019
- Date of Event
- June 27, 2019
- Report Date
- September 23, 2019
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 30382903825333
- PMA / PMN Number
- K110443
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
CORRECTION: UPDATED LOT#, DIFFERENT LOTS BEING SPLIT FOR DIFFERENT DATES OF EVENT ADDED NEW DATE OF EVENT AND FACILITY ADDRESS ADDED ADDRESS AND ZIP. THE FOLLOWING INFORMATION HAS BEEN UPDATED: D.4. MEDICAL DEVICE LOT #: 9018511, E.1. INITIAL REPORTER E-MAIL: (B)(6), E.1. INITIAL REPORTER ADDRESS 1: (B)(6) AND E.1. INITIAL REPORTER ZIP: (B)(6).
H.6. INVESTIGATION SUMMARY. DHR REVIEWS WERE PERFORMED ON LOT NUMBERS 9081511. -- THE LOT NUMBER WAS MANUFACTURED / PACKAGED ON AFA LINE 11 FROM 26MAR2019 THRU 29MAR2019 FOR THE QUANTITY (B)(4) UNITS -- REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. -- REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS RELEVANT TO THE ALLEGED DEFECT FOR THIS LOT NUMBER. (B)(4) -- THE LOT NUMBER WAS MANUFACTURED / PACKAGED ON AFA LINE 11 FROM 06NOV2018 THROUGH 11NOV2018 FOR THE QUANTITY OF (B)(4) UNITS. -- REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. -- REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS RELEVANT TO THE ALLEGED DEFECT FOR THIS LOT NUMBER. THE DEFECT LEAKAGE; COULD NOT BE IDENTIFIED OR CONFIRMED, AND CAUSE COULD NOT BE DETERMINED, AS THE UNITS DESCRIBED IN THE PRODUCT INCIDENT REPORT WERE NOT RETURNED FOR EVALUATION AND TESTING. INDETERMINATE ¿ WITHOUT THE ACTUAL SAMPLE FOR EVALUATION AND TESTING THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.
IT HAS BEEN REPORTED THAT THE 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC HAS EXPERIENCED LEAKAGE AT THE CATHETER DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 382533 BATCH NO.: 9081511, 8310640. IT WAS REPORTED THAT THE CATHETERS ARE LEAKING. CATH ARE LEAKING. MATERIAL NUMBER: 382533, LOTS: 9081511, 8310640.
IT HAS BEEN REPORTED THAT THE 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC HAS EXPERIENCED LEAKAGE AT THE CATHETER DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 382533 BATCH NO.: 9081511, 8310640. IT WAS REPORTED THAT THE CATHETERS ARE LEAKING. CATH ARE LEAKING. MATERIAL NUMBER: 382533. LOTS: 9081511, 8310640.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9081511, MEDICAL DEVICE EXPIRATION DATE: 2022-02-28, DEVICE MANUFACTURE DATE: 2019-03-22. MEDICAL DEVICE LOT #: 8310640, MEDICAL DEVICE EXPIRATION DATE: 2021-10-31, DEVICE MANUFACTURE DATE: 2018-11-06.
IT HAS BEEN REPORTED THAT THE 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC HAS EXPERIENCED LEAKAGE AT THE CATHETER DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 382533, BATCH NO.: 9081511, 8310640. IT WAS REPORTED THAT THE CATHETERS ARE LEAKING. CATH ARE LEAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 580760 | 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC | INTERVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 9018511 | 30382903825333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |