MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL W/NDL 21X1-1/2 RB; PISTON SYRINGE

Model Number	309643
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/02/2020
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 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 the syringe 10ml ll w/ndl 21x1-1/2 rb experienced discolored/stained primary packaging.The following information was provided by the initial reporter: customer received 400 each of item 309643/106005l, lot number 0238480, expiring 07-31-2025 on po 20809.
Additional Manufacturer Narrative
H6: investigation summary two photos displaying two 100-count shelf cartons from batch 0238480 (p/n 309643) were received and evaluated.A device history review was conducted for lot number 0238480.The cartons were opened and contained an unknown number of syringes inside.It was observed, the top layer of blister packs inside the carton had gross ink stains, which were rejectable per product specification.Potential root cause for the ink stain defect is associated with the packaging process.It was likely the printer faulted after a power dip that caused a utility failure.
Event or Problem Description
It was reported that the syringe 10ml ll w/ndl 21x1-1/2 rb experienced discolored/stained primary packaging.The following information was provided by the initial reporter: customer received 400 each of item 309643/106005l, lot number 0238480, expiring 07-31-2025 on po 20809.

• Brand Name: SYRINGE 10ML LL W/NDL 21X1-1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10908873
• Report Number: 1213809-2020-00839
• Device Sequence Number: 14205006
• Product Code: FMF
• UDI-Device Identifier: 30382903096436
• UDI-Public: 30382903096436
• 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: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

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: 07/31/2025
• Device Model Number: 309643
• Device Catalogue Number: 309643
• Device Lot Number: 0238480
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 12/06/2020
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1