MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 10ML E/T WITH US GRAPHICS; PISTON SYRINGE

Model Number	305482
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Occupation: senior specialist, quality assurance and regulatory affairs.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 25 syringes 10ml e/t with us graphics had poor package sterility.The following information was provided by the initial reporter: "it was reported that the packages were received damaged as the paper appeared to not react well with the sterilization process.Event description per attached email states: quick question, a customer received syringe 305482 where the paper did not react well to the sterilization process.".
Event or Problem Description
It was reported that (b)(4) syringes 10ml e/t with us graphics had poor package sterility.The following information was provided by the initial reporter: "it was reported that the packages were received damaged as the paper appeared to not react well with the sterilization process.Event description per attached email states: quick question, a customer received syringe 305482 where the paper did not react well to the sterilization process.".
Additional Manufacturer Narrative
H.6.Investigation: three photos were received by our quality team for evaluation.Upon visual inspection of these photos, the damaged packaged was not able to be confirmed, therefore the incident could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.H3 other text : see h.10.

• Brand Name: SYRINGE 10ML E/T WITH US GRAPHICS
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10160191
• Report Number: 8041187-2020-00340
• Device Sequence Number: 11662648
• Product Code: FMF
• UDI-Device Identifier: 30382903054825
• UDI-Public: 30382903054825
• 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): 06/19/2020

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: 05/31/2023
• Device Model Number: 305482
• Device Catalogue Number: 305482
• Device Lot Number: 8142303
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2020
• Supplement Date Received by Manufacturer: 05/25/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 06/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other