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 Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: two samples were received.One sample is from bd and the other from a competitor (excelsior medical).Both have plunger rod-rubber stopper, tip cap, solution and barrel label.The bd sample is according to the product specification.The sample from the competitor has a handwritten note on the packaging flow wrap as ¿ideal¿ with an arrow pointing to a linear bar code printed on the packaging flow wrap.The bd sample/ products do not have this linear bar code printed on the flow wrap.The bd sample has a handwritten note as ¿not ideal¿.Potential root cause when the udi 2.0 barcode was implemented, the linear barcode was eliminated.The lack of linear barcode has induced customer dissatisfaction.The samples are to be send to the posiflush platform for awareness.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: both samples came with sealed packaging flow wrap.One sample is from bd and the other from a competitor (excelsior medical).Both have plunger rod-rubber stopper, tip cap, solution and barrel label.The bd sample is according to the product specification.Root cause description: potential root cause when the udi 2.0 barcode was implemented, the linear barcode was eliminated.The lack of linear barcode has induced customer dissatisfaction.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that the 2d barcode on the syringe 5ml heparin 100 unit label was observed to be missing before use.The following information was provided by the initial reporter: "bd 100ml heparin flush syringe missing 2d barcode.".

• 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: 9124009
• Report Number: 1911916-2019-01011
• Device Sequence Number: 18984293
• Product Code: NZW
• UDI-Device Identifier: 30382903064244
• UDI-Public: 30382903064244
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K090680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 306424
• Device Lot Number: 827580N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other