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

Catalog Number 300865

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

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

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).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 with the use of the bd plastipak¿ concentric luer lock syringe there was an issue with difficult plunger movement.It was stated ¿during an exhibition the consumer set up infusion pumps and syringes and when checking the syringes it was realized that two syringes from the same batch differed in resistance when moving the plunger.On one syringe it moves fine and on one it moves with more resistance.Same syringe, same batch, different resistance in the barrel.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

H.6.Investigation summary: three sample units were received for evaluation by our quality engineer team.Upon examination of the samples, no damages or molding defects were observed on any of the components.A device history record review (dhr) of lot 1612256p showed no anomalies during the production of the provided lot number that could have contributed to the reported defect.Break out force, sustaining force, and silicone content tests are performed during production.The provided samples were within specifications.As no defects could be found on the provided samples or from the production history a definite cause for the issue reported could not be determined.Final products are sampled from the manufacturing line and subjected to visual and functional inspections to prevent the distribution of defective product.Silicone content test and break out-sustaining force tests are done during manufacturing process per lot according to procedures.On checking the results for these tests on lot 1612256p they are within specification limits.Since no incidence happened during manufacturing process and according to results obtained from test carried out, the samples received meet iso7886 annex d, and it can be confirmed no manufacturing defect has been found on them.So a definitive root cause cannot be determined.Based on severity and occurrence no formal capa is required according to internal procedure.

• Brand Name: BD PLASTIPAK¿ CONCENTRIC 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: 7515618
• MDR Text Key: 108509461
• Report Number: 3003152976-2018-00198
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

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: Other
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 300865
• Device Lot Number: 1612256P
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 05/08/2018
• Supplement Dates FDA Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other