MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 5ML LL W/NEEDLE 22X1-1/2IN RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305785
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 5ml ll w/needle 22x1-1/2in rb barrel was deformed.The following information was provided by the initial reporter: distorted barrel.
Event or Problem Description
It was reported that syringe 5ml ll w/needle 22x1-1/2in rb barrel was deformed.The following information was provided by the initial reporter: distorted barrel.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-03-01.H6: investigation summary: one photo and one sample was received by our quality team for evaluation.From the photo, the syringe is observed to be damaged.The sample was subjected to visual inspection.Damage near the barrel roof, zero line scale mare is printed lower, and a scratch mark on the syringe barrel body was observed.A device history record review found no non-conformances associated with this issue during production of this batch.The syringe assembly line was reviewed.Different machine sections were reviewed to match the potential area which could cause the damaged barrel.Based on the returned sample evaluation, it was observed that the barrel is damaged near to the barrel roof and zero scale line is printed lower.The probable cause could be due to the molded barrel is slanted and jammed at the barrel infeed station.The defective parts could have been failed to be effectively removed by the production technician which resulted in escapees to the printing process.Therefore, at the printing process, the zero line is printed lower due to the damaged barrel.H3 other text : see h10.

• Brand Name: SYRINGE 5ML LL W/NEEDLE 22X1-1/2IN RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11426839
• Report Number: 8041187-2021-00160
• Device Sequence Number: 2856193
• Product Code: FMI
• UDI-Device Identifier: 00382903057856
• UDI-Public: 00382903057856
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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 Expiration Date: 01/31/2025
• Device Catalogue Number: 305785
• Device Lot Number: 0057551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 03/07/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1