MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/BLUNT PLASTIC CANN; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	303346
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1008436.Medical device expiration date: 2025-12-31.Device manufacture date: 2021-01-08.Medical device lot #: 1043495.Medical device expiration date: 2026-01-31.Device manufacture date: 2021-02-12.Medical device lot #: 0353219.Medical device expiration date: 2025-11-30.Device manufacture date: 2020-12-18.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 syringe 3ml ll w/blunt plastic cann broke.The following information was provided by the initial reporter: material no.: 303346 batch no.: 1008436, 1043495, 0353219.It was reported that a piece of the syringe/cannula breaks off and it is difficult to push the cannula through.Per response email: these devices were being used on the rubber vial stoppers to pull up the medication, not the actual cap.They were extremely hard to push in and when we did get them in the vials, there were visible fragments in vial and pulled up into the syringe.
Event or Problem Description
It was reported that syringe 3ml ll w/blunt plastic cann broke.The following information was provided by the initial reporter: material no.: 303346 batch no.: 1008436, 1043495, 0353219 it was reported that a piece of the syringe/cannula breaks off and it is difficult to push the cannula through.Per response email: these devices were being used on the rubber vial stoppers to pull up the medication, not the actual cap.They were extremely hard to push in and when we did get them in the vials, there were visible fragments in vial and pulled up into the syringe.
Additional Manufacturer Narrative
H.6.Investigation: samples from three syringe batches, one needle batch, and one non-bd product were received: 164 sealed packaged syringes from batch #1008436 (p/n 303346).91 sealed packaged syringes from batch #1043495 (p/n 303346).74 sealed packaged syringes from batch #0353219 (p/n 303346).294 sealed packaged and 1 loose blunt plastic cannulas from batch #0252728 (p/n 303345).1 sealed package from non-bd monoject cannula by covidien.None of the cannula products were made at this syringe manufacturing plant and therefore were not evaluated.The three syringe batches were sampled for 81 total pieces (27 from each) and had their cannulas visually evaluated.No cracks, damage, deformities or other rejectable defects were observed in the samples.The reported defect was not identified in the samples received.It is possible the product was not used properly.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.

• Brand Name: SYRINGE 3ML LL W/BLUNT PLASTIC CANN
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11803513
• Report Number: 1213809-2021-00305
• Device Sequence Number: 19711688
• Product Code: FMI
• UDI-Device Identifier: 00382903033461
• UDI-Public: 00382903033461
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 05/24/2021

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 Catalogue Number: 303346
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1