MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE; PISTON SYRINGE

Model Number	309579
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that 4 bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needles experienced product damage/deformation with the device still considered operable.Product defect was noted prior to use.The following information was provided by the initial reporter: material no.:309579 batch no.:9175481.The administrator at the user facility emailed me stating they have opened four syringes that have had cracked barrels.The ref number 309579, which is 3ml syringes w/ 20g x 1 1/2 in.Needle.The lot number on them is 9175481.She said it isn't a huge deal but wanted to let us know and how odd it was.The box and packaging that they came in have not showed any signs of damage.
Additional Manufacturer Narrative
H.6.Investigation: one loose 3ml syringe and an opened blister pack from batch 9175481 (p/n(b)(6)) were received and evaluated.It was observed the issue was a lengthwise crack in the barrel of the syringe extending from the 0.5ml to the 2.5ml marking, which was rejectable per product specification.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 9175481 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.A potential root cause for the cracked barrel defect is associated with the assembly process.No corrective actions are necessary based on the defective rate identified.Batch 9175481 is considered in compliance with our product specification requirements.
Event or Problem Description
It was reported that 4 bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needles experienced product damage/deformation with the device still considered operable.Product defect was noted prior to use.The following information was provided by the initial reporter: material no.: (b)(6) batch no.: 9175481 the administrator at the user facility emailed me stating they have opened four syringes that have had cracked barrels.The ref number 309579, which is 3ml syringes w/ 20g x 1 1/2 in.Needle.The lot number on them is 9175481.She said it isn't a huge deal but wanted to let us know and how odd it was.The box and packaging that they came in have not showed any signs of damage.

• Brand Name: BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10188117
• Report Number: 1213809-2020-00413
• Device Sequence Number: 14270477
• Product Code: FMF
• UDI-Device Identifier: 30382903095798
• UDI-Public: 30382903095798
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2020

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: 06/30/2024
• Device Model Number: 309579
• Device Catalogue Number: 309579
• Device Lot Number: 9175481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 07/07/2020
• 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