MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 60ML E/T; PISTON SYRINGE

Model Number	300866
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/10/2020
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.(b)(4).
Event or Problem Description
It was reported that syringe 60ml e/t was bent.The following information was provided by the initial reporter: bend straight.
Event or Problem Description
It was reported that syringe 60ml e/t was bent.The following information was provided by the initial reporter: bend straight.
Additional Manufacturer Narrative
H.6.Investigation: one unused sample of lot 2003201 was provided to our quality team for investigation.The product was visually inspected and the tip is observed to be bent.A device history review was performed for reported lot 2003201, finding one annotation related to the alleged defect.During the assembly process, a failure was detected in the assembly machine that resulted in product jamming within the equipment.H3 other text : see h.10.

• Brand Name: SYRINGE 60ML E/T
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 10954450
• Report Number: 3003152976-2020-00547
• Device Sequence Number: 16319172
• Product Code: FMF
• UDI-Device Identifier: 30382903008668
• UDI-Public: 30382903008668
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 12/09/2020

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: 02/28/2025
• Device Model Number: 300866
• Device Catalogue Number: 300866
• Device Lot Number: 2003201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1