MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE; SYRINGE WITH NEEDLE

Catalog Number 320119

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/07/2017

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: n/a.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported the consumer had multiple needles that remained in injection site after delivery.The needles dislodged from base of hub and the consumer required ultrasounds, internal radiology and surgery to remove the needles.Consumer reports that there are no lasting side or further treatment pending.

Manufacturer Narrative

Results: bd received twelve (12) 5mm, 31g bd pen needles; 10 were received sealed and 2 were without the tear drop label.Consumer reported seeing two hubs and needles after removing tear drop label.The two open returned pen needles were examined; one had an outer cover the other needle it was without an outer cover (just the hub and the needle were seen).There were no manufacturing defects found on either returned open pen needles.Multiple attempts were made to try to fit both hubs and needles into the one outer cover returned, but it was not possible.The alleged defect (two hubs/needles into one outer cover) could not be confirmed.The remaining 10 pen needles returned sealed were also examined.All 10 were opened and tested to make sure only one hub and needle were inside each outer cover.All 10 were found to be per specification.No manufacturing defect could be found.A review of the device history record revealed no irregularities during the manufacture of the reported lot number.Bd was not able to duplicate or confirm the customer¿s indicated failure.Conclusion: root cause cannot be determined at this time as the issue is unconfirmed.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer (Section G): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7144342
• MDR Text Key: 95722996
• Report Number: 9616656-2017-00185
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10885403811012
• UDI-Public: 10885403811012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

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 Catalogue Number: 320119
• Device Lot Number: 7032826
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 11/07/2017
• Supplement Dates FDA Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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): Hospitalization; Required Intervention