MAUDE Adverse Event Report: BD CARIBE LTD. 22 G X 3 1/2 IN. BD¿ QUINCKE SPINAL NEEDLE, BLACK HUB; ANESTHESIA SPINAL NEEDLE

Catalog Number 405181

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Code Available (3191)

Event Date 07/07/2016

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

During a left shoulder arthrogram, the clinician attempted removing the needle used for contrast injection.At the end of the procedure, the needle tip broke off and remained in the subscapularis tendon in the patient's left shoulder.A ct was used to view the needle fragment and the needle was removed under sedation and using fluoroscopy.

Manufacturer Narrative

Additional information from medwatch: per report, the needle tip that broke off was 2.5cm and it had a 90 degree bend in it (as seen on ct).Initial reporter also sent report to the fda, yes or no.This information was submitted by the customer via medwatch reference#mw5063485.

Event Description

Additional information from medwatch: per report, the needle tip that broke off was 2.5cm and it had a 90 degree bend in it (as seen on ct).

Manufacturer Narrative

Initial sample investigation: one used sample was returned for evaluation.The returned sample was visually examined for customer¿s reported issue.Sample revealed broken needle.Photos were taken and the sample was forwarded to the manufacturing site for a secondary investigation.At the date of this report, the sample has not yet been evaluated by the manufacturing site.However, the quality engineer evaluated the photos taken during the initial investigation and verified the needle had bent and broken off.Conclusion not yet available - evaluation in progress.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.

Manufacturer Narrative

Results: three (3) photos and the actual suspect device was submitted and examined visually which confirmed the condition of the broken needle.After sample evaluation, it was found that the condition is not related to the manufacturing process.The manufacturing and inspection records of the lot concerned were reviewed and no abnormality which could be related to the reported event was found.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5254988.Conclusion: an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customers indicated failure mode.The condition of the device may be related to the insertion technique.

• Brand Name: 22 G X 3 1/2 IN. BD¿ QUINCKE SPINAL NEEDLE, BLACK HUB
• Type of Device: ANESTHESIA SPINAL NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5845080
• MDR Text Key: 51120329
• Report Number: 2618282-2016-00005
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/15/2016

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: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 405181
• Device Lot Number: 5254988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2016
• Initial Date FDA Received: 08/03/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/09/2016; 09/09/2016; 09/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2015
• 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): Required Intervention