MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD PRECISIONGLIDE¿ SYRINGE WITH HYPODERMIC NEEDLE; PISTON SYRINGE

Model Number 309575

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2021

Event Type  malfunction  

Event Description

It was reported that the bd precisionglide¿ syringe with hypodermic needle had white powder in the hub of syringe.The following information was provided by the initial reporter: our customer reported finding contamination (looks like white powder) in the needle hub of a 3ml syringe which we dispensed product into and sent them.

Manufacturer Narrative

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

Manufacturer Narrative

H.6.Investigation: one photo was received and evaluated.The photo displayed a loose 3ml syringe with needle (p/n 309575).It was observed that a white piece of foreign matter was inside of the collar and appeared to be attached to the needle.The foreign matter appeared to be epoxy from the needle manufacturing process and was non-conforming per product specification.Potential root cause for foreign matter defect is associated with the needle supplier¿s manufacturing process.The photo was forwarded to the needle supplier for further evaluation and investigation.Further investigation was performed at needle manufacturing site.Based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.Potential root cause for foreign matter defect is associated with assembly line.The misfeeding of the cannulator may have induced to have the epoxy on the needle hub.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h.10.

Event Description

It was reported that the bd precisionglide¿ syringe with hypodermic needle had white powder in the hub of syringe.The following information was provided by the initial reporter: our customer reported finding contamination (looks like white powder) in the needle hub of a 3ml syringe which we dispensed product into and sent them.

• Brand Name: BD PRECISIONGLIDE¿ SYRINGE WITH HYPODERMIC NEEDLE
• Type of Device: PISTON 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13122301
• MDR Text Key: 285406180
• Report Number: 1213809-2021-00830
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903095750
• UDI-Public: 30382903095750
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309575
• Device Catalogue Number: 309575
• Device Lot Number: 1104781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/07/2022
• Supplement Dates FDA Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• 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