MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK LUER-LOK 30 ML SYRINGE; PISTON SYRINGE

Catalog Number 301229

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 before use of the bd plastipak¿ luer-lok¿ 30 ml syringe there was an issue with foreign matter.The following information was provided by the initial reporter: i am the lead qa for our aseptic unit and we have identified some failed 30 ml syringes during our preparation stage in aseptic production.Product reference 301229 (30 ml bd luer-lok syringes) batch number: 1909206 we have currently identified nine affected syringes from two boxes of this batch number, with a further three boxes awaiting to be used in our unit, which we have quarantined.

Manufacturer Narrative

H.6.Investigation summary: a total of nine samples and four photos were provided to our quality team for investigation.Upon visual inspection, fibers were observed inside the syringe.Using magnification, the fibers were identified to be polypropylene particles.These particles generate during the transport and molding process of the pieces in the manufacturing equipment.A device history review was performed for reported lot 1811230, no deviations or non-conformances related to the reported issues were identified during the manufacturing process.Manufacturing for this product is performed in a clean room which is kept under a positive pressure to reduce the chance of foreign matter and machines routinely undergo proper maintenance and cleaning.Manufacturing personnel have been made aware of this experience to increase awareness of this matter.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.H3 other text : see section h.10.

Event Description

It was reported that before use of the bd plastipak¿ luer-lok¿ 30 ml syringe there was an issue with foreign matter.The following information was provided by the initial reporter: i am the lead qa for our aseptic unit and we have identified some failed 30ml syringes during our preparation stage in aseptic production.Product reference 301229 (30ml bd luer-lok syringes) batch number: 1909206 we have currently identified nine affected syringes from two boxes of this batch number, with a further three boxes awaiting to be used in our unit, which we have quarantined.

• Brand Name: BD PLASTIPAK LUER-LOK 30 ML SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 9528103
• MDR Text Key: 208192514
• Report Number: 3003152976-2019-00888
• 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: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301229
• Device Lot Number: 1909206
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other