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	12/28/2020
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 a syringe 60ml e/t had the tip damaged at an unspecified time.The following was reported by the initial reporter: "the tip bent".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 1/22/2021.H.6.Investigation: one sealed sample of lot 1911289 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 marking process, a failure was detected related to an increased speed in the conveyor belt that transfers the syringes to the marking machine which resulted in product getting damaged.The mechanical team repaired the failure and impacted units were scrapped.It was determined the issue reported is related to this malfunction.
Event or Problem Description
It was reported that a syringe 60ml e/t had the tip damaged at an unspecified time.The following was reported by the initial reporter: "the tip bent".

• 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: 11202808
• Report Number: 3003152976-2021-00043
• Device Sequence Number: 2140215
• Product Code: FMF
• UDI-Device Identifier: 30382903008668
• UDI-Public: 30382903008668
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2021

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: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: 300866
• Device Catalogue Number: 300866
• Device Lot Number: 1911289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1