MAUDE Adverse Event Report: BD CARIBE LTD. NEEDLE SPINAL S/SU 18GA 6IN QUINCKE; ANESTHESIA CONDUCTION NEEDLE

Model Number	408360
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8123805, medical device expiration date: 2023-05-31, device manufacture date: 2018-07-02.Medical device lot #: 9088609, medical device expiration date: 2024-03-31, device manufacture date: 2019-05-29.Pma/510(k)#: preamendment.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that an unspecified number of needle spinal s/su 18ga 6in quincke experienced product damage/deformation -device still operable, and were involved in a serious injury in the form of medical intervention.During treatment, a portion of the device became embedded within the patient's kidney and had to be removed by a health care professional.No additional information regarding the outcome of this medical intervention has been specified.The following information was provided by the initial reporter: the device in question is: aig pl 150mm 18g 408360, ref: 408360 and number of series: 8123805 and 9088609.The problem encountered is: "during an nlpc (nephrolithotomy per cutaneous) use of the spinal needle to locate the kidney.Smaller needle diameter at the end of the needle impeding the passage of the guide that "spins" and can't remove the guide." clinical consequences: "rupture of part of the guide wire in the patient's kidney.This part had to be recovered.".
Event or Problem Description
It was reported that an unspecified number of needle spinal s/su 18ga 6in quincke experienced product damage/deformation -device still operable, and were involved in a serious injury in the form of medical intervention.During treatment, a portion of the device became embedded within the patient's kidney and had to be removed by a health care professional.No additional information regarding the outcome of this medical intervention has been specified.The following information was provided by the initial reporter: the device in question is: aig pl 150mm 18g 408360, ref: 408360 and number of series: (b)(6).The problem encountered is: "during an nlpc (nephrolithotomy per cutaneous) use of the spinal needle to locate the kidney.Smaller needle diameter at the end of the needle impeding the passage of the guide that "spins" and can't remove the guide." clinical consequences: "rupture of part of the guide wire in the patient's kidney.This part had to be recovered ".
Additional Manufacturer Narrative
H.6.Investigation summary: bd has not been provided with photos or samples for catalog 408360 lots 8123805 and 9088609 to investigate for this record.Unfortunately, as a result, bd was unable to verify the reported issue or determine a definitive root cause.The device history review was performed and no discrepancies were observed.The most probable root cause is related to off-label use of the product.The use of the guide wires are not applicable to spinal needles.No corrective actions are required at this time.H3 other text : see section h.10.

• Brand Name: NEEDLE SPINAL S/SU 18GA 6IN QUINCKE
• Common Device Name: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 9667274
• Report Number: 2618282-2020-00004
• Device Sequence Number: 16844079
• Product Code: BSP
• UDI-Device Identifier: 30382904083602
• UDI-Public: 30382904083602
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: SEE H.10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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
• Operator of Device: Other
• Device Model Number: 408360
• Device Catalogue Number: 408360
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other