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

Catalog Number 300865

Device Problem Fungus in Device Environment (2316)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the bd plastipak¿ 50ml concentric luer lock syringe experienced mold presence.The following information was provided by the initial reporter: contaminated syringe.Grey contaminant, appearing like mold inside top of syringe surface.Also transferred onto black plunger.

Manufacturer Narrative

The following fields were updated due to corrected information: d.4.Medical device lot #: unknown.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 1/21/2021.H.6.Investigation: it was reported that a syringe had grey contaminant, appearing like mold inside the top of the syringe.To aid in the investigation, one physical sample and two photos were provided for evaluation by our quality team.The sample received is a 50ml luer lock syringe that came with no packaging blister.A visual inspection was performed and foreign matter was observed adhered to the stopper.It appears to be silicone and is about 1/32" in size.No other defects or imperfections were observed.The sample was then taken to a laboratory for analysis and testing for mold.The test results came back negative.The two photos provided show the sample received.It could be possible that the silicone applied to the inner wall of the barrel and rubber stopper was viewed in a way that looked like foreign matter.Based on the investigation with the sample analysis the mold symptom reported by the customer could not be confirmed.A device history record review could not be completed for this complaint as the material and lot numbers are 'unknown.' h3 other text : see h.10.

Event Description

It was reported that the bd plastipak¿ 50ml concentric luer lock syringe experienced mold presence.The following information was provided by the initial reporter: contaminated syringe.Grey contaminant, appearing like mold inside top of syringe surface.Also transferred onto black plunger.

• 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: 11285476
• MDR Text Key: 230756292
• Report Number: 3003152976-2021-00065
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1