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

Patient Problem No Code Available (3191)

Event Date 06/15/2016

Event Type  Injury  

Manufacturer Narrative

Medical device lot #; medical device expiration date; section h, device manufacture date.The exact lot number involved in this incident is unknown.The customer provided the following potential lot numbers: 4162967 - medical device expiration date 06/30/2019, device manufacture date 06/11/2014.5062666 - medical device expiration date 03/31/2020, device manufacture date 03/03/2015.5114909 - medical device expiration date 05/31/2020, device manufacture date 04/24/2015.Device evaluation: it is unknown if a sample will be returned for evaluation.A supplemental report will be filed upon completion of the investigation.

Event Description

It was reported that the suspect device broke off while it was inserted in a patient.The patient had surgical removal of the broken piece of needle.The needle was successfully retrieved and the patient didn't require further intervention.

Manufacturer Narrative

Device evaluation: result - bd received for investigation four bd 27ga 3 ½¿ whitacre spinal needles (cat # 405079, possible lots # 5062666, 4162967, 5114909), two with open blisterpack and two with no packaging.The returned samples were visually examined for customer¿s reported issue.It was indicated that one needle was returned broken.A review of the device records revealed no abnormalities during the manufacturer of the reported potential lot numbers.All inspections were performed accordingly and met qc specifications and no ncmr's were generated that could be related to the reported event.A manufacturing review was performed and no abnormalities were reported.Conclusion - bd was able to confirm the customer's indicated failure mode.The reported condition of broken needle based on the investigation results is not related to manufacturing.The failure mode could be associated to the insertion technique used by the physician.As the actual lot number involved in this incident was not provided, an absolute root cause cannot be determined.

• 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: 5826894
• MDR Text Key: 50582743
• Report Number: 2618282-2016-00004
• 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: 09/09/2016

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 Catalogue Number: 405079
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2016
• Initial Date FDA Received: 07/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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