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

Model Number 001151-30C

Device Problems Break (1069); Crack (1135); Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 05/22/2017

Event Type  Injury  

Event 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
• Type of Device: ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• MDR Report Key: 6720647
• MDR Text Key: 80253916
• Report Number: 9611612-2017-00006
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223000059
• UDI-Public: 14048223000059
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 129