MAUDE Adverse Event Report: BD CARIBE LTD. 27 G X 4 11/16 IN. BD¿ LONG LENGTH WHITACRE SPINAL NEEDLE; ANESTHESIA SPINAL NEEDLE

Catalog Number 409443

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 10/26/2015

Event Type  Injury  

Manufacturer Narrative

The date of event is unknown.The device received by the manufacturer is used.It is unknown what lot number was used in this incident.Potential lot numbers provided: 1042886, 5014957, 4283881, 4258798.As the lot number is unknown, the device expiration date is unknown.As the lot number is unknown, the device manufacture date is unknown.A sample is available for evaluation but has not been received by the manufacturer.A supplemental report will be filed upon completion of the investigation.

Event Description

It was reported that a non-bd catheter was placed by an experienced anesthetist using a bd whitacre spinal needle.When the catheter was removed approximately 48 hours after the procedure, the patient experienced csf leakage.The patient had skin sutures placed to stop the csf leakage.It was reported that there were no perceived complications that occurred during the procedure.

Manufacturer Narrative

Evaluation: received unused 27g whitacre needles (cat # 409443) from the following lots: 5014957 - 6 samples, 5064758 - 1 sample, 3140317 - 1 sample, 4258798 - 11 samples, 4283881 - 3 samples, 1042886 - 2 samples.Of note, the initial complaint and mdr did not include lot numbers 5064758 and 3140317.Although these samples were returned by the customer, it is unclear whether these are also suspect devices related to this incident.Result: the returned product was visually examined and no molding defects were observed on the points of any of the needles that could potentially lead to the condition of csf leakage.It was observed that the hub design is different on product from lot numbers 1042886 and 3140317.Additionally, for lot 4258798, one sample was observed to have a bent needle.An evaluation of the device history records were performed to look at conditions related to bent needles, needle hub design, and needle point quality.No needle point non-conformances were observed during the manufacturing of the needle lots that could potentially lead to the leaking of csf when the needle is used as intended.Specific device history review for each lot are as follows: -no abnormalities were reported during the manufacture of the received lot numbers 5064758, 3140317, and 1042886.-for lot 5014957, the device history record revealed no abnormalities except for one machine breakdown that was generated in the molding machine not related to the condition of bent needle, needle point damage, and/or hub design change.-for lot 4258798, the device history record revealed no abnormalities except one non-conformance that was generated during the needle assembly process.It was generated during in-process leak testing.The affected product was discarded and all inspections were performed accordingly and met qc specifications.The failure mode was investigated and does not appear to be related to the complaint incident.A leaking needle will be identified at the point of administering the medication during the procedure.The leakage will be seen either at the luer connection section or at the needle to hub connection area.This effect will not be seen 48 hours after.-for lot 4283881, the device history record revealed no abnormalities except for one machine breakdown that was generated in the molding machine not related to the condition of bent needle, needle point damage, and or/hub design change.All inspections were performed accordingly and met qc specifications.A review of the manufacturing process revealed no changes have been performed that could affect assembly process of the needles.No changes have occurred to the cannula and/or stylets design and the manufacturing process used for the assembly of the needles that could potentially create the condition of csf leak or bent needles.The changes observed on the hub design from lots 3140317 and 1042886 vs.The other returned samples is due to the change in the molding/assembly process at the manufacturing site.The difference in hub designs is not a non-conformance.The change on the molding process of the hub is not related to the condition of csf leakage or bent needles.Conclusion: the customer complaint for csf leak is unconfirmed.This condition can possibly occur due to a puncture of the dura during the procedure application.The conditions of hub design change and bent needle are confirmed.The root cause related to the condition of csf leak cannot be determined to be related to the needle assembly process.Csf leak can occur during the application process due to dura puncture/penetration.The root cause for the design change observed on the hubs is related to the change in molding/assembly process at the manufacturing site.The root cause related to the condition of bent needle can be assigned to an escape from the assembly process.Bent needle observed in the sample can occur while inserting the shield into the needle already assembled.An absolute root cause for this incident cannot be determined.

• Brand Name: 27 G X 4 11/16 IN. BD¿ LONG LENGTH WHITACRE SPINAL 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: 5234253
• MDR Text Key: 31568141
• Report Number: 2618282-2015-00006
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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?: No
• Device Operator: Physician
• Device Catalogue Number: 409443
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 11/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/10/2015
• 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