MAUDE Adverse Event Report: BD CARIBE LTD. NEEDLE SP S/SU 27GA 4-11/16IN WHITACRE; ANESTHESIA CONDUCTION NEEDLE

Model Number	409443
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.Root cause description: root cause cannot be determined at this time as no sample, batch, or lot code was provided.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the needle sp s/su 27ga 4-11/16in whitacre broke off in the patient, resulting in unexpected medical intervention and a delay in treatment.This complaint was created to capture the 3rd of 4 related incidents.The following information was provided by the initial reporter: "(b)(6) - foreign body in patient, unexpected medical intervention, delay to treatment/(b)(4), break".
Additional Manufacturer Narrative
The following information has been updated: b.5 describe event or problem: it was reported that the needle sp s/su 27ga 4-11/16in whitacre broke off in the patient, resulting in unexpected medical intervention and a delay in treatment.This complaint was created to capture the 3rd of 4 related incidents.The following information was provided by the initial reporter: while performing spinal anaesthesia, a 5cm to 6cm section of the spinal needle broke off inside patient¿s back.Neurosurgeon was consulted and removed foreign body under local anaesthesia.A second attempt at spinal anaesthesia was successful, and original procedure proceeded as scheduled.H3 other text : see h10.
Event or Problem Description
It was reported that the needle sp s/su 27ga 4-11/16in whitacre broke off in the patient, resulting in unexpected medical intervention and a delay in treatment.This complaint was created to capture the 3rd of 4 related incidents.The following information was provided by the initial reporter: while performing spinal anaesthesia, a 5cm to 6cm section of the spinal needle broke off inside patient¿s back.Neurosurgeon was consulted and removed foreign body under local anaesthesia.A second attempt at spinal anaesthesia was successful, and original procedure proceeded as scheduled.
Event or Problem Description
It was reported that the needle sp s/su 27ga 4-11/16in whitacre broke off in the patient, resulting in unexpected medical intervention and a delay in treatment.This complaint was created to capture the 3rd of 4 related incidents.The following information was provided by the initial reporter: while performing spinal anaesthesia, a 5cm to 6cm section of the spinal needle broke off inside patient¿s back.Neurosurgeon was consulted and removed foreign body under local anaesthesia.A second attempt at spinal anaesthesia was successful, and original procedure proceeded as scheduled.
Additional Manufacturer Narrative
H6: investigation summary bd was unable to perform a thorough investigation as no sample or batch number were provided.A dhr was not performed as the lot number is "unknown" for this complaint.

• Brand Name: NEEDLE SP S/SU 27GA 4-11/16IN WHITACRE
• Common Device Name: ANESTHESIA CONDUCTION 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 ; 8015296192
• MDR Report Key: 11095611
• Report Number: 2618282-2020-00108
• Device Sequence Number: 19002033
• Product Code: BSP
• UDI-Device Identifier: 30382904094431
• UDI-Public: 30382904094431
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2023

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: 409443
• Device Catalogue Number: 409443
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 08/31/2022; 01/03/2023
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 10/01/2022; 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown