MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 22X1 RB; PISTON SYRINGE

Catalog Number	309572
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/07/2020
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 and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that syringe 3ml ll w/ndl 22x1 rb had scale marking issues.The following information was provided by the initial reporter: material no.: 309572 batch no.: 0071482.It was reported that 4 syringes were missing 1 empty sealed bag, and scale printing is poor.Customer response: the veterinary practices has informed our quebec contact that the lot and expiry date is the same as the one in my email.We have asked them to put the remaining 2 boxes aside.Per email: we have a customer that is reporting issues with your bd 3ml 22gx1'' product.They have indicated that out of the box of 100 units, 4 syringes were missing.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl 22x1 rb had scale marking issues.The following information was provided by the initial reporter: material no.: 309572 batch ,no.: 0071482.It was reported that 4 syringes were missing 1 empty sealed bag, and scale printing is poor.Customer response: the veterinary practices has informed our quebec contact that the lot and expiry date is the same as the one in my email.We have asked them to put the remaining 2 boxes aside.Per email: we have a customer that is reporting issues with your bd 3ml 22gx1'' product.They have indicated that out of the box of 100 units, 4 syringes were missing.
Additional Manufacturer Narrative
Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were 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.

• Brand Name: SYRINGE 3ML LL W/NDL 22X1 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11108356
• Report Number: 1213809-2020-00941
• Device Sequence Number: 3595929
• Product Code: FMF
• UDI-Device Identifier: 00382903095728
• UDI-Public: 00382903095728
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (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): 01/07/2021

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: 02/28/2025
• Device Catalogue Number: 309572
• Device Lot Number: 0071482
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1