MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY SYRINGE 30ML LS S/C 56; PISTON SYRINGE

Catalog Number	302833
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2019
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 a syringe 30ml ls s/c 56 had foreign matter.The following was reported, "it was found that foreign matter on barrel.".
Additional Manufacturer Narrative
Investigation: two (2) photos were provided by the customer for investigation by the quality team.Each photo shows a syringe with brown spots embedded in the barrels.On 02-apr-2019 the two (2) samples were received.Both samples have brown spots embedded in the barrels.One sample also has brown spots embedded in the flange.The brown spots were determined to be burnt plastic.A device history record review found no non-conformances associated with this issue during production of this batch.Based upon the quality team's investigation, the root cause of this issue is related to the molding process during the manufacturing of the syringe.In may 2018, there was a manufacturing process improvement to reduce the occurrence of this defect.The batch associated with this complaint was produced in 2017 prior to the implementation of this change.
Event or Problem Description
It was reported that a syringe 30ml ls s/c 56 had foreign matter.The following was reported, " it was found that foreign matter on barrel.".

• Brand Name: SYRINGE 30ML LS S/C 56
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 8444359
• Report Number: 1911916-2019-00301
• Device Sequence Number: 2887337
• Product Code: FMF
• UDI-Device Identifier: 00382903028337
• UDI-Public: 00382903028337
• 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): 04/09/2019

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: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 302833
• Device Lot Number: 7179512
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 04/09/2019
• 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