MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD 20 ML SYRINGE W/ NEEDLE

Catalog Number 301948

Device Problems Fungus in Device Environment (2316); Packaging Problem (3007)

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

Event Date 07/10/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: bd has been provided with photos and samples for catalog 301948 lot 1710230 to investigate for this record.Visual examination of the photos and samples seems have been wet and damaged before arrival to the customer.As a result, bd was able to verify the reported issue.The most probable root cause could be related to the storage or transport of the product after production.As it relates to the manufacturing process, bd was unable to determine a root cause.Considering our in-coming and in-process inspection and since this is the first time this lot is reported for this defect, no corrective actions are required at this time.Investigation conclusion: after the revision of the bhr and registers of c-047 "revision of damaged material in handling / storage procedures", bd has determined that no re-work was done with product of this batch.Bd has not been able to establish the specific root cause thereby incur the reported issue.The most probably root cause could be related to the storage or transport of the product after production.According to above results, root cause analysis is not possible to determine, but we should stand out that this is an uncommon issue and the occurrence chances are practically negligible.Root cause description: possible damage of the product during storage or transport after the manufacturing process.Rationale: we can ensure that the probability of finding this kind of defect is isolated and any recurrence is really unlikely in our products since review syringe dhr showed no indication of the alleged defect, considering our in-coming and in-process inspection and since this is the first time this lot is reported for this defect, no actions are required.

Event Description

It was reported that bd¿ 20 ml syringe w/ needle had a mark on the packaging.This occurred on 4240 occasions before use.The following information was provided by the initial reporter: noticed mold mark on 4240 eas packaging after product arrival.Defected product didn't used.

• Brand Name: BD 20 ML SYRINGE W/ NEEDLE
• Type of Device: SYRINGE W/ NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8843396
• MDR Text Key: 160867982
• Report Number: 3002682307-2019-00420
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 301948
• Device Lot Number: 1710230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other