MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIC NON-STERILE 5ML LUER-LOK¿ TIP SYRINGE

Catalog Number 301027

Device Problems Difficult to Remove (1528); Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/10/2017

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.(b)(4).

Event Description

It was reported that the stopper of the bd 10ml syringe was difficult to move and when it was moved there was visible residue on the inside surface of the syringe barrel.After observing this residue the plunger that moves without difficulties.There were no medical interventions because of this incident.

Manufacturer Narrative

Based on samples received from lot 7153990 and p/n 301027, no defects were confirmed on the 6 syringes received.The 5ml syringes perform as expected for functionality.Additionally, a review of the device history record for lot 7153990 and p/n 301027 was performed.Lot 7153990 was released to the market on (b)(6) 2017.All visual inspections were performed as per requirement with no quality notifications created.Lot 7153990 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Based on the investigation results a root cause for this incident cannot be determined.

Manufacturer Narrative

On 10/10/2017 the product catalog and lot number was updated per samples received.

• Brand Name: BD PLASTIC NON-STERILE 5ML LUER-LOK¿ TIP SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6759188
• MDR Text Key: 81688322
• Report Number: 1213809-2017-00051
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 301027
• Device Lot Number: 7153990
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2017
• Initial Date FDA Received: 08/01/2017
• Supplement Dates Manufacturer Received: 07/11/2017; 07/11/2017
• Supplement Dates FDA Received: 09/19/2017; 11/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2017
• 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