MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX DURAFLEX EPIDURAL CATHETER LUER PLUG; CATHETER, CONDUCTION, ANESTHETIC

Model Number	6947-02
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter: address not provided.
Event or Problem Description
Information was received that a smiths medical portex duraflex epidural catheter luer plug needle broke off inside of a patient.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
17 unused kitswere received in the box for evaluation.The actual compromised sample, mentioned in the complaint was not available for evaluation.All 17 unused samples were visually examined with unaided eye, no anomalies could be observed.The samples were found to be fully formed, without any visible defects and properly assembled.All 17 samples were then evaluated per incoming inspection specification for raw material catheter 20g-all noted to be within specification.The catheters were also tested for tensile strength, and percent elongation and all 17 samples met established specification for these as well.Based on the available evidence, the problem reported by the customer could not be confirmed, and the problem source could not be determined.

• Brand Name: PORTEX DURAFLEX EPIDURAL CATHETER LUER PLUG
• Common Device Name: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8741527
• Report Number: 3012307300-2019-02876
• Device Sequence Number: 1330065
• Product Code: BSO
• UDI-Device Identifier: 00351688056071
• UDI-Public: 00351688056071
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D029630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 02/08/2022
• Device Model Number: 6947-02
• Device Catalogue Number: 6947-02
• Device Lot Number: 3777641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1