MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK 50ML LUER-LOK SYRINGE

Catalog Number 300865

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that bd plastipak¿ 50 ml luer-lok syringe plunger broke during use.The following information was provided by the initial reporter: during the preparation of a syringe into a syringe infusion pump, the plunger broke when the medication was being withdrawn.

Event Description

It was reported that bd plastipak¿ 50ml luer-lok syringe plunger broke during use.The following information was provided by the initial reporter: during the preparation of a syringe into a syringe infusion pump, the plunger broke when the medication was being withdrawn.

Manufacturer Narrative

H.6.Investigation: two photos were provided to our quality team for investigation.Through visual inspection, the plunger rod was noted to be damaged on one side.A device history review was performed for reported lot 2005214, no deviations or non-conformances related to the reported issues were identified during the manufacturing process.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.The areas where pieces run in the manufacturing area are protected to avoid damage on the product.While we could not identify a direct issue, it was determined the damage was likely due to the product jamming within the manufacturing equipment.A project, c-526-19, was initiated to reduce damage on our product.

• Brand Name: BD PLASTIPAK 50ML LUER-LOK SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 10370351
• MDR Text Key: 202935635
• Report Number: 3003152976-2020-00344
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: 2005214
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other