MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE; ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT

Model Number	001151-30C
Medical Device Problem Codes	Break (1069); Crack (1135); Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Inadequate Pain Relief (2388)
Date of Event	05/22/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Irn# (b)(4).From customer experience form sent back to mfr: needle bent.From medwatch report: event desc: patient was admitted to labor and delivery for a c-section.During regional anesthesia placement by physician, the spinal needle broke.An approximate three inch segment of the needle remained embedded in patient's back.After completion of the c-section, the needle was successfully removed by the physician.The incision was closed with silver nitrate, surgical skin glue, and steri strips.The patient tolerated the procedure well; no complications.The incident was explained to the patient and her husband.Patient was discharged within normal / expected time frame for c-section with no complications.What was the original intended procedure? regional anesthesia.

• Brand Name: SPROTTE
• Common Device Name: ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• MDR Report Key: 6720647
• Report Number: 9611612-2017-00006
• Device Sequence Number: 10810076
• Product Code: BSP
• UDI-Device Identifier: 14048223000059
• UDI-Public: 14048223000059
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K911202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/18/2017

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
• Operator of Device: Other
• Device Expiration Date: 12/01/2020
• Device Model Number: 001151-30C
• Device Catalogue Number: 001151-30C
• Device Lot Number: 1141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 07/18/2017
• 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: Required Intervention
• Patient Age: 30 YR
• Patient Weight: 129