MAUDE Adverse Event Report: BECTON DICKINSON AND CO. PN 31X8 FRANCE 100BX; NEEDLE

Catalog Number 325108

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that pn 31x8 france 100bx needle broke off inside the patient and remained in the arm.This was discovered during use.The following information was provided by the initial reporter: please register a new material vigilance declaration made this morning by the pharmacy.A customer reported to her by phone that she had had a pb with a needle.The needle broke cleanly at the base and remained implanted in the arm of the patient, his son.

Manufacturer Narrative

Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A lot history review was carried out and no related non conformance's were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.

Event Description

It was reported that pn 31x8 france 100bx needle broke off inside the patient and remained in the arm.This was discovered during use.The following information was provided by the initial reporter: please register a new material vigilance declaration made this morning by the pharmacy.A customer reported to her by phone that she had had a pb with a needle.The needle broke cleanly at the base and remained implanted in the arm of the patient, his son.

• Brand Name: PN 31X8 FRANCE 100BX
• Type of Device: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 9310243
• MDR Text Key: 173981373
• Report Number: 9616656-2019-01107
• Device Sequence Number: 1
• Product Code: JKA
• 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: 12/04/2019

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: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 325108
• Device Lot Number: 9121982
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 10/28/2019
• Supplement Dates FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other