MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 25 G X 5/8 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE; SYRINGE AND NEEDLE

Catalog Number 305269

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/06/2015

Event Type  Injury  

Manufacturer Narrative

Evaluation: a sample is available for investigation but has not been received by the manufacturer.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that when the consumer's wife was using the device to administer his coumadin replacement, the device's needle broke off in his body.The consumer went to the emergency department where they detected the needle on x-ray, but no further interventions were performed.The consumer was told that the needle will work it's way out on it's own and no additional follow up was scheduled.

Manufacturer Narrative

Result - received one used, activated bd 3ml 25g integra syringe with 5/8" retractable needle out of open blisterpack.The returned syringe was broken down and revealed the needle was retracted and resting inside the barrel.A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 4086029.(b)(4).

• Brand Name: 25 G X 5/8 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE
• Type of Device: SYRINGE AND NEEDLE
• 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: 5177839
• MDR Text Key: 29251836
• Report Number: 1213809-2015-00009
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011103
• 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: 11/23/2015

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?: No
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 305269
• Device Lot Number: 4086029
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2015
• Initial Date FDA Received: 10/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention