MAUDE Adverse Event Report: HOSPIRA, LTD LTXFR NV TUR Y-SET; CATHETER IRRIGATION

Catalog Number	06543
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tubing set was discarded by the customer; however, the sister sample is expected to be returned for investigation.It has not yet been received.
Event or Problem Description
During a cystoscopy-ureteroscopy with retrograde pyelogram and left stent insertion/removal procedure on a (b)(6) male, the customer alleged the tip of the iv spike broke off and went into the patient¿s bladder.The surgeon retrieved the broken piece of the tip.The customer reported the patient was fine and that there was no injury or otherwise adverse event.
Additional Manufacturer Narrative
Testing and investigation examined a piece of the spike; the sister sample of the tubing set was not received for evaluation.The complaint was confirmed, but a probable cause could not be determined.Additionally, a batch record review revealed no discrepancies that may have contributed to a complaint of this nature and all quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the final visual, physical evaluation results indicated that the product met specification requirements.
Event or Problem Description
During a cystoscopy-ureteroscopy with retrograde pyelogram and left stent insertion/removal procedure on a (b)(6) male, the customer alleged the tip of the iv spike broke off and went into the patient¿s bladder.The surgeon retrieved the broken piece of the tip.The customer reported the patient was fine and that there was no injury or otherwise adverse event.

• Brand Name: LTXFR NV TUR Y-SET
• Common Device Name: CATHETER IRRIGATION
• Manufacturer (Section D): HOSPIRA, LTD; 9613251; carretera sanchez km. 18 1/2; haina sancristobal ; DR
• MDR Report Key: 7331692
• Report Number: 9613251-2018-00001
• Device Sequence Number: 10919738
• Product Code: GBX
• UDI-Device Identifier: 10887787006725
• UDI-Public: (01)10887787006725(17)200301(10)75241NS
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K841362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2018

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: Health Professional
• Device Catalogue Number: 06543
• Device Lot Number: 75241NS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 05/07/2018
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 76