MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE NON STERILE 50ML LL

Catalog Number 300223

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 04/18/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 that an unspecified number of syringe non sterile 50ml ll experienced product damage and leakage.The following information was provided by the initial reporter: customer reported that the syringe is leaking considerably, there is a huge crack on the syringe lengthwise.Product: 300223, batch 1610704p.The syringe has been filled and was already in the pump for administration, but fortunately (because of the risk of contamination) it has not yet been administered.

Manufacturer Narrative

Investigation: one sample and one photo were provided to our quality engineer for investigation.Through visual inspection, a crack is observed on the barrel, extending to the 40 ml marking.A device history review was performed for reported lot 1610704p, finding one annotation that could be related to the reported defect.During the marking process, a malfunction was detected in the marking machine that resulted in barrels becoming jammed in the barrel feeding wheel.Once detected, the mechanical team repaired the failure and impacted units were scrapped.It was determined the issue you reported is related to this malfunction.

Event Description

It was reported that an unspecified number of syringe non sterile 50ml ll experienced product damage and leakage.The following information was provided by the initial reporter: customer reported that the syringe is leaking considerably, there is a huge crack on the syringe lengthwise.Product: 300223, batch 1610704p.The syringe has been filled and was already in the pump for administration, but fortunately (because of the risk of contamination) it has not yet been administered.

• Brand Name: SYRINGE NON STERILE 50ML LL
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8579784
• MDR Text Key: 145282051
• Report Number: 3003152976-2019-00306
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 300223
• Device Lot Number: 1610704P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Date Manufacturer Received: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other