MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ SLIP TIP STERILE SYRINGE; PISTON SYRINGE

Catalog Number	302833
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/27/2018
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 with the use of the bd¿ slip tip sterile syringe there was an issue with barrel with brown foreign matter.
Additional Manufacturer Narrative
H.6.Investigation summary: one sample was received for evaluation.It has embedded particles in the barrel wall.Two photos were provided, both photos show the sample with the embedded particles in the barrel wall.Failure mode is verified.Embedded foreign matter can occur at the startup of an injection mold/press or intermittently during the injection molding process.Degraded resin inherently builds up in the barrel and hot-runner system of the mold and press.The degraded resin can break loose and be molded into components.This is a cosmetic defect only and does not affect the integrity of the syringe.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.This is the 4th complaint for the lot# 7179512 for the same defects or symptoms.There was no documentation of issues for the complaint of lot # 7179512 during this production run.
Event or Problem Description
It was reported with the use of the bd¿ slip tip sterile syringe there was an issue with barrel with brown foreign matter.

• Brand Name: BD¿ SLIP TIP STERILE SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8242267
• Report Number: 1911916-2018-00821
• Device Sequence Number: 11249392
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2019

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: 12/27/2018
• Supplement Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 02/18/2019
• 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