MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD PLASTIPAK LUER-LOK SYRINGE; PISTON SYRINGE

Catalog Number 302149

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: two photos and one sample were received by our quality team for evaluation.From the photo, a visible layer of coating on the rubber stopper was observed.From the returned sample, the team observed visible lubrication residue on the rubber stopper.The sample was subjected to the silicone content test and was within specification.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.From the returned observed visible lubrication (silicone) residue on the syringe rubber stopper.The silicone which was the only liquid material spray on the syringe barrel in the syringe assembly process is for easy withdrawal of the plunger.The sample passed the silicone content test and within specification, therefore the root cause could not be determined.This incident has been added to our database of reported incidents.

Event Description

It was reported when using the bd plastipak¿ luer-lok¿ syringe there was foreign matter on device cannula/needle/syringe or any fluid path component.The following information was provided by the initial reporter.The customer stated: there was "excessive lubricant on the plunger in the syringe body.".

• Brand Name: BD PLASTIPAK LUER-LOK SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12556889
• MDR Text Key: 274563014
• Report Number: 8041187-2021-00876
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302149
• Device Lot Number: 0359183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1