MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 3ML HEPARIN 100 UNIT; HEPARIN, VASCULAR ACCESS FLUSH

Model Number 306423

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 09/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: a device history record review was performed for provided lot number 831991n.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this incident, 5 picture samples were received for evaluation by our quality team.Through examination of the samples, the photos show shelf boxes a syringe from the lot number 831991n and from the lot number 911354n.The boxes are taped with clear tape with the bd logo, and this tape was added at distribution centers/ warehouses.Investigation conclusion: our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.Root cause description: the cause of this defect resulted from a mix up at the supply chain, however the exact location this occurred is unknown.Rationale: further action has not been determined necessary at this time.

Event Description

It was reported that syringe 3ml heparin 100 unit came with a mix of product types.This occurred on 30 occasions before use.The following information was provided by the initial reporter: 30 pcs of posiflush 3 ml heparin saline received inside box of 5 ml heparine saline.That is also near expiry with expiry date of 30-nov-2020.

• Brand Name: SYRINGE 3ML HEPARIN 100 UNIT
• Type of Device: HEPARIN, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10614409
• MDR Text Key: 209846154
• Report Number: 1911916-2020-00913
• Device Sequence Number: 1
• Product Code: NZW
• UDI-Device Identifier: 30382903064237
• UDI-Public: 30382903064237
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K163591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2020
• Device Model Number: 306423
• Device Catalogue Number: 306423
• Device Lot Number: 831991N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other