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

Catalog Number 309581

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/21/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: unknown.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that bd syringe with bd precisionglide¿ needle detached and remained in the patient's arm.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no: 309581, batch no: unknown.It was reported by the distributor that the customer has been experiencing ongoing issues with the needle detaching and remaining in the patient's arm.Event description per distributor's complaint form states, "some needles remaining in arm after injection.".

Event Description

It was reported that bd syringe with bd precisionglide¿ needle detached and remained in the patient's arm.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no: 309581 batch no: unknown.It was reported by the distributor that the customer has been experiencing ongoing issues with the needle detaching and remaining in the patient's arm.Event description per attached distributor's complaint form states, "some needles remaining in arm after injection.".

Manufacturer Narrative

Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review could not be performed as lot number was unknown.

• Brand Name: BD SYRINGE WITH BD PRECISIONGLIDE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8489899
• MDR Text Key: 141359873
• Report Number: 1213809-2019-00418
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903095811
• UDI-Public: 30382903095811
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• 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: 04/24/2019

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: Other
• Device Catalogue Number: 309581
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2019
• Initial Date FDA Received: 04/07/2019
• Supplement Dates Manufacturer Received: 03/21/2019
• Supplement Dates FDA Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Other