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

Catalog Number	302833
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that two syringe 30ml ls s/c 56 experienced product damage/deformation and was still operable.The following information was provided by the initial reporter: after opening the unit package, it was found that the flange broken , and the broken part isn't in the unit package.
Additional Manufacturer Narrative
Investigation: one (1) photo was provided by the customer for investigation.The photo shows a syringe which has part of one (1) flange broken off.One (1) photo was provided by the customer for investigation.The photo shows a syringe which has part of one (1) flange broken off.A device history record (dhr) review was performed on the batch associated with this investigation.The dhr review revealed a comment that stated that a keyway on the ionizer dial had become worn which caused excessive movement of the dials which led to barrels jamming in the dials on the ionizer station.This issue could have caused occasional damage to the barrels which was not detected during the in process inspections.
Event or Problem Description
It was reported that two syringe 30ml ls s/c 56 experienced product damage/deformation and was still operable.The following information was provided by the initial reporter: after opening the unit package, it was found that the flange broken , and the broken part isn't in the unit package.

• 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: 8616091
• Report Number: 1911916-2019-00479
• Device Sequence Number: 2494983
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 302833
• Device Lot Number: 8107603
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/03/2019
• 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