MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK SYRINGE

Catalog Number 300865

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd plastipak¿ syringe had foreign matter in it.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: i am sending you this email to let you know that we had a 50ml syringe on which there was still a residual of colour (in my opinion).The exact reference of the syringe is 300865.This is the batch: 1810227 with an expiry date of 09/2023.

Manufacturer Narrative

Investigation: one sample and three photos were provided to our quality engineer for investigation.Through visual inspection, black spots were observed on the barrel.Further evaluation determined the spots to consist of embedded polypropylene material from the molding process.A device history review was performed for reported lot 1810227 , no deviations or non-conformances related to the reported issues were identified during the manufacturing process.Machines routinely undergo proper maintenance and cleaning and product is both visually and functionally tested to avoid any defects.This is a cosmetic defect that will not affect the functionality of the syringe.

Event Description

It was reported that bd plastipak¿ syringe had foreign matter in it.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: i am sending you this email to let you know that we had a 50ml syringe on which there was still a residual of colour (in my opinion).The exact reference of the syringe is 300865.This is the batch: 1810227 with an expiry date of 09/2023.

• Brand Name: BD PLASTIPAK SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8527047
• MDR Text Key: 144138526
• Report Number: 3003152976-2019-00274
• 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
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 300865
• Device Lot Number: 1810227
• Date Manufacturer Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other