MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 25 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE; SYRINGE AND NEEDLE

Catalog Number 305270

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 10/16/2015

Event Type  Injury  

Manufacturer Narrative

The medical device expiration date is unknown as the lot number is unknown.The device manufacture date is unknown as the lot number is unknown.A sample is available for evaluation but has not been received.A supplemental report will be filed upon completion of the investigation.

Event Description

It was reported that when the patient was removing the bd integra¿ 3 ml syringe with detachable needle from the injection site, she heard a snap.She stated she did not insert the needle all the way into her arm, saw the needle sticking out of her arm, and then it sucked into the site.The patient went to the emergency department where they performed an x-ray, ct scan, and ultrasound.Two needles were discovered.One was in the arm and the other had migrated to the shoulder.The emergency department personnel were unsuccessful in removing the needle from her arm.The patient was seen by an orthopedic surgeon on (b)(6).Additional imaging was performed and it was confirmed that the needles were migrating closer to the bone.No surgical intervention was performed at this time.The patient is in a lot of pain and is on pain medication.She states she will be returning to the orthopedic surgeon for further follow up.

Manufacturer Narrative

Evaluation: result - a sample was not returned for evaluation.A review of the device history record cannot be completed as the lot number was not provided for this incident.Conclusion - a potential root cause for this incident is reuse.Without a sample, an absolute root cause for this incident cannot be determined.A sample was not returned for evaluation.

• Brand Name: 25 G X 1 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: 5224535
• MDR Text Key: 31196043
• Report Number: 1213809-2015-00013
• 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: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 305270
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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