MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY 30 ML BD LUER-LOK TIP SYRINGE; PISTON SYRINGE

Catalog Number	303346
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that breakage occurred with a 30 ml bd luer-lok¿ tip syringe.The following information was provided by the initial reporter, "the product that we been purchasing has been difficult for the physicians in the er, the luer-lok tip with blunt plastic cannula.We are wondering if there's any product that might be stronger on the tip of this item.I believe that when they insert it the tip will bend or break.".
Event or Problem Description
It was reported that breakage occurred with a 30 ml bd luer-lok¿ tip syringe.The following information was provided by the initial reporter, "the product that we been purchasing has been difficult for the physicians in the er, the luer-lok tip with blunt plastic cannula.We are wondering if there's any product that might be stronger on the tip of this item.I believe that when they insert it the tip will bend or break.".
Additional Manufacturer Narrative
H.6.Investigation: two photos, one unopened 100-count carton and fifteen 3ml syringes with blunt cannulas in fully sealed blister packs confirmed to be from batch 9028859 (p/n 303346) were received and evaluated.One of the photos displayed a vial and septum with holes poked through the top.No visual defects were observed with the cannulas.The reported defect was not identified in the samples received.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.H3 other text : see h.10.

• Brand Name: 30 ML BD LUER-LOK TIP SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 8905985
• Report Number: 1911916-2019-00832
• Device Sequence Number: 2000661
• Product Code: FMF
• UDI-Device Identifier: 30382903033462
• UDI-Public: 30382903033462
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

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: 12/31/2023
• Device Catalogue Number: 303346
• Device Lot Number: 9028859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 09/17/2019
• 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