MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SYRINGE; SALINE FLUSH

Catalog Number 306594

Device Problem Material Discolored (1170)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd posiflush¿ syringe had a solution that was "yellowed when opened the unit package".Found before use.No serious injury or medical intervention reported.

Event Description

It was reported that bd posiflush¿ syringe had a solution that was "yellowed when opened the unit package".Found before use.No serious injury or medical intervention reported.

Manufacturer Narrative

Investigation summary: a sample was received for evaluation.It has the packaging flow wrap, the plunger rod-rubber stopper, the tip cap and saline solution.The barrel label confirms the lot# 7279528.The solution shows discoloration.There is no loose foreign matter in the solution.The plunger rod - rubber stopper was removed for visual inspection and the stoppers shows two spots with embedded foreign matter.Failure mode is verified.The rubber stopper is a supplied part.Upon analysis of the part by the supplier, it was noted that there were 2 inclusions.The first inclusion was found to be consistent with polydimethylsiloxane.The second was found to be consistent with thermally degraded cellulose and polydimethylsiloxane.Polydimethylsiloxane is a silicone.Silicone is used throughout manufacturing as a processing aid.Silicone ids in preventing the parts from sticking inside and mold cavities during molding, and prevents the parts from sticking to each other during trimming, washing, tumbling and after being packed.The silicone used during manufacturing is an emulsion, and appears light in color.The presence of silicone on the parts is expected.The darkened color of the silicone observed is from exposure to heat during molding.The presence of cellulose most likely came from the gowning material worn by the operator.A device history record review was completed and there was no issues with discoloration during production run for batch 7279528.Investigation conclusion: unable to determine a root cause.

• Brand Name: BD POSIFLUSH¿ SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7656606
• MDR Text Key: 113202758
• Report Number: 1911916-2018-00389
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

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
• Device Operator: Nurse
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 306594
• Device Lot Number: 7279528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 07/02/2018
• Supplement Dates Manufacturer Received: 06/11/2018
• Supplement Dates FDA Received: 08/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other