MAUDE Adverse Event Report: BD CARIBE LTD. 27 G X 3 1/2 IN. BD¿ WHITACRE HIGH FLOW, PENCIL POINT NEEDLE; ANESTHESIA SPINAL NEEDLE

Catalog Number 405079

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 11/04/2015

Event Type  Injury  

Manufacturer Narrative

A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 5062666.(b)(4) device samples from the reported lot number were received sealed and within the packaging.One used sample with a fractured needle was received within a separate canister.The used sample was visually examined and was confirmed for the stated defect.Conclusion: this complaint is confirmed based on visual inspection.The samples were sent to the manufacturing site for further investigation.See report for investigation results.

Event Description

It was reported that during the insertion of a bd¿ whitacre needle, the middle of the needle broke off and was left between the vertebrae in the patient's lower back.The patient required an emergency surgery with fluoroscopy under general anesthesia to remove the needle.The incision was 7-8 cm long by 7-8 cm deep.

Manufacturer Narrative

Result - the samples were received by the manufacturing site for additional evaluation.A visual evaluation of the returned sample shows that the needle was broken.In addition, the needle appears to be bent.A review of the manufacturing process and device history record revealed no abnormalities during the manufacture of the reported lot number 5062666.A quality notification review was conducted for the cannula component and no ncmr's and/or scars were generated for conditions related to broken needle.Conclusion - although an absolute root cause for this incident cannot be determined, the quality engineer states that based on previous investigations and sample evaluation showing that the needle was bent, this defect could potentially be due to error in user technique.This may be caused by the spinal needle being bent off axis in some manner and withdrawing the needle through the introducer, engaging the sharp bell of the introducer needle and fracturing on the point of the introducer needle.Another potential root cause is excessive bending and/or restraightening of the needle.No possible cause has been identified for this complaint related to the manufacturing process.See report for investigation results.

• Brand Name: 27 G X 3 1/2 IN. BD¿ WHITACRE HIGH FLOW, PENCIL POINT NEEDLE
• 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: 5259043
• MDR Text Key: 32456590
• Report Number: 2618282-2015-00008
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 405079
• Device Lot Number: 5062666
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/09/2015
• Initial Date FDA Received: 12/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2014
• 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