MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ 30ML LUER-LOCK SYRINGE

Catalog Number 301229

Device Problem Material Separation (1562)

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

Event Date 06/18/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: unknown.Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported with the use of the bd plastipak¿ 30ml luer-lock syringe there was an issue with stopper separation from plunger.It was stated by the consumer ¿the rubber on the plunger has slipped.It is on the side.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Investigation summary: one sample unit and two pictures were received for evaluation by our quality engineer.Upon visual inspection of the samples, the stopper was observed misassembled within the syringe and it was distorted against the barrel walls.No damages or molding defects were observed to the plunger rod or to the stopper that could have caused this defect.As a lot number is unknown for this incident, a production history review could not be performed.Within the assembly station of the manufacturing line, there is a photo-cell which detects wrongly assembled stoppers and syringes without stoppers.The disassembled stopper is a result of a misalignment of the plunger, stopper, and barrel in the assembly station.A project has been opened to reduce the occurrence of this defect.Improvements will include mechanical changes in the assembly station and a new vision system to detect the defective product.

Event Description

It was reported with the use of the bd plastipak¿ 30ml luer-lock syringe there was an issue with stopper separation from plunger.It was stated by the consumer ¿the rubber on the plunger has slipped.It is on the side.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: yes.

Event Description

It was reported with the use of the bd plastipak¿ 30ml luer-lock syringe there was an issue with stopper separation from plunger.It was stated by the consumer ¿the rubber on the plunger has slipped.It is on the side.¿ there was no report of injury or further medical intervention.

• Brand Name: BD PLASTIPAK¿ 30ML LUER-LOCK SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7681320
• MDR Text Key: 114032577
• Report Number: 3003152976-2018-00277
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301229
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other