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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that syringe 60ml e/t had a deformed stopper.The following information was provided by the initial reporter: "50 cc empty needle body splits a punch arc".
Event or Problem Description
It was reported that syringe 60ml e/t had a deformed stopper.The following information was provided by the initial reporter: "50 cc empty needle body splits a punch arc".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-05-07.Investigation summary: one photo and one sample was provided to our quality team for investigation.Upon visual inspection, the barrel is observed to have a transversal cut.A device history record review found no non-conformances associated with this issue during production of lot 2007081, however, a daily incident report did detect an issue in the packaging machine which can be related to the observed damage.During the packaging process, a maladjustment of the transversal blade which separates the blisters into strips was detected.As a result of the maladjustment, damage to the barrel can occur, the blades cutting in the incorrect location.Final products in this manufacturing line, for this reference and lot size are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Given there was no damage to the packaging, it was determined the damaged packaging was identified during manufacturing and the device was reprocessed and repackaged, however, the damage on the barrel was not observed before repackaging; therefore the product was not properly discarded.Manufacturing personnel have been notified of this incident to increase awareness of this matter.Complaints received for this device and defect will be monitored by our quality team for signs of emerging trends.

• 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: 11863143
• Report Number: 3003152976-2021-00277
• Device Sequence Number: 16942371
• 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
• 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,Followup
• Report Date (Section B): 06/24/2021

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 Expiration Date: 06/30/2025
• Device Model Number: 300866
• Device Catalogue Number: 300866
• Device Lot Number: 2007081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 07/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1