MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 30ML LS S/C 56; PISTON SYRINGE

Model Number	302833
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8360688.Medical device expiration date: 2023-12-31.Device manufacture date: 2018-12-26.Medical device lot #: 8360690.Medical device expiration date: 2023-12-31.Device manufacture date: 2018-12-26.Medical device lot #: 9029908.Medical device expiration date: 2024-01-31.Device manufacture date: 2019-01-29.Investigation summary: it was reported there are impurities in the barrels and packaging.To aid in the investigation, three photos were provided for evaluation by our quality team.One photo shows a plastic bag with packaging blisters inside.Another photo shows two packaging blisters with what appears to be residues of ink in the sealing area of the top-bottom web of the packaging blisters.The third photo shows two packaging blisters.Another one a burnt top-bottom web packaging blister.A device history record review was completed for provided material number 302833, lot numbers 8360688, 8360690 and 9029908.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defects.Verification of the packaging process was performed.No conditions were found that could induce the symptoms and the flow of products was good.To date, there have been no other similar events reported for these lots.Investigation conclusion: based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.We will continue monitoring the complaint trend for the product and symptom.Probable root cause.It could be possible that the printer was not properly cleaned inducing residues to the packaging blister.A jam may have occurred while sealing the top-bottom web inducing the burnt bottom-top webs.Verification of the packaging process was performed.Including printing and sealing finding no conditions that could induce the symptoms reported by the customer.Flow of products was also good.
Event or Problem Description
It was reported that 37 syringe 30ml ls s/c 56 experienced foreign matter in the fluid pathway.The following information was provided by the initial reporter: lot number 8360688: 5 syringes have impurities in the barrel, and 6 suspected molds are found in the packaging and the barrel; lot no.8360690: there are impurities in the barrel of 8 syringes; lot no.9029908: 1 syringe has impurities in the barrel and packaging, 3 syringes have impurities in the packaging, 13 tubes have impurities, and 1 syringe has found suspected mold on the packaging and the barrel wall.

• Brand Name: SYRINGE 30ML LS S/C 56
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 12422298
• Report Number: 1911916-2021-00929
• Device Sequence Number: 11693971
• Product Code: FMF
• UDI-Device Identifier: 30382903028338
• UDI-Public: 30382903028338
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 08/23/2021

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 Model Number: 302833
• Device Catalogue Number: 302833
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1