MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 5ML HEPARIN 100 UNIT; HEPARIN, VASCULAR ACCESS FLUSH

Catalog Number	306424
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306424 and lot number 929492n.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Investigation conclusion: complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Root cause description: based on the investigation results, an exact cause for this incident could not be identified.Rationale: there are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Capa not required at this time.
Event or Problem Description
It was reported that syringe 5ml heparin 100 unit was damaged.This occurred on 3 occasions.The following information was provided by the initial reporter: customer has worked with the heparin lock flush solution usp product in several presentations for a long time without observations.Now in particular has received report of batch (b)(4) of the 100 units/ml 5ml presentation, that in 3 patients it was not obtained the expected permeability, that's why they sent an e-mail to find out if there was any deviation of the concentration in the batch of this matter, or if there was another report from other customers.

• Brand Name: SYRINGE 5ML HEPARIN 100 UNIT
• Common Device Name: HEPARIN, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 11369479
• Report Number: 1911916-2021-00152
• Device Sequence Number: 3743424
• Product Code: NZW
• UDI-Device Identifier: 00382903064243
• UDI-Public: 00382903064243
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K163591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 306424
• Device Lot Number: 929492N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1