MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 20X1-1/2 RB; PISTON SYRINGE

Model Number	309579
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that 4 syringes 3ml ll w/ndl 20x1-1/2 rb had a cracked barrel.The following information was provided by the initial reporter: "it was reported that 4 syringes were found to have the barrel cracked.(b)(4).Per pir: the administrator at columbus surgery center 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.Her staff did save her one for reference.".
Event or Problem Description
It was reported that 4 syringes 3ml ll w/ndl 20x1-1/2 rb had a cracked barrel.The following information was provided by the initial reporter: "it was reported that 4 syringes were found to have the barrel cracked.(b)(4) captures the incident date on (b)(6) 2020.(b)(4) captures the incident date on (b)(6) 2020.Per pir: the administrator at (b)(6) center emailed me stating they have opened four syringes that have had cracked barrels.The ref number: (b)(4), 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.Her staff did save her one for reference.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 6/10/2020.H.6.Investigation: one loose 3ml syringe with an opened blister pack from batch: 9175481 (p/n: 309579) were received and evaluated.It was observed there was a large lengthwise crack extending from the 0.3ml to the 2.5ml grad line with a small indentation in the center.The cracked barrel was rejectable per product specification.Dhr was performed.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.

• Brand Name: SYRINGE 3ML LL W/NDL 20X1-1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10196821
• Report Number: 1213809-2020-00420
• Device Sequence Number: 14270478
• 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): 07/24/2020

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: 06/25/2020
• Supplement Report FDA Received Date: 07/24/2020
• 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