FDA Adverse Event
Malfunction
Summary report: N
IVT DISPOSABLE
MDR report key: 3150729
·
Received June 6, 2013
Report
- Report Number
- 1416980-2013-14543
- Event Type
- Malfunction
- Date Received
- June 6, 2013
- Date of Event
- March 10, 2013
- Report Date
- May 14, 2013
- Manufacturer
- BAXTER HEALTHCARE - THETFORD
- Product Code
- LHI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION IT WAS IDENTIFIED THAT THE BLISTER PACKAGING DID NOT HAVE A STRONG BOND BETWEEN THE BLISTER AND THE BACKING PAPER. THE CAUSE OF THE REPORTED MALFUNCTION IS UNKNOWN. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE.
Additional Manufacturer Narrative · 1
(B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THE PAPER BACKING ON A VIALMATE ADAPTOR USED FOR THE ADMINISTRATION OF CEFUROXIM 5 GRAMS MIXED WITH SODIUM CHLORIDE (NACL) 9MG/ML HAD ALREADY DETACHED WHEN OPENING THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250912 | IVT DISPOSABLE | SET, I.V. FLUID TRANSFER | LHI | BAXTER HEALTHCARE - THETFORD | 12L12VM03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |