MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE

Catalog Number 300865

Device Problems Product Quality Problem (1506); Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that there were different diameters of barrels of the bd plastipak¿ 50ml concentric luer lock syringe, that were not compatible with the syringe pump.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: five unused sample units were received for evaluation by our quality engineer.Upon visual inspection of the samples, no damages or molding defects were observed that could have related to the reported defect of pump incompatibility.The external diameter of the barrel was measured using a coordinate measuring machine; all five samples were within specifications.As a lot number was unknown, a device history record review for the product in question could not be performed.No changes have been made in the syringe dimensions or the syringe molds for this product.As no defects or anomalies were observed on the provided samples, a definite cause for the reported defect 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.Based on severity and occurrence no formal capa is required according to internal procedure.

Manufacturer Narrative

H.6.Investigation results: no photos or samples were received by our quality team for evaluation therefore failure mode could not be verified and root cause could not be determined.With no known lot number a device history record review, nor an evaluation of retained samples can be performed.We can confirm that no changes in syringe dimensions have been done in the molds for this reference.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.With the info available and since no samples have been received, no further investigation can be done and the root cause of the alleged defect cannot be determined.Based on severity and occurrence no formal capa is required according to internal procedure.

• Brand Name: BD PLASTIPAK¿ 50ML 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: 7485692
• MDR Text Key: 107594460
• Report Number: 3003152976-2018-00159
• 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: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other