MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP INTERMITTENT CATHETER TRAY

Model Number	INTS14C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that straight catheter kits were leaking at the connection site to the drain bag.Per follow-up on 17jun2021, it was reported that two staff had brought this forward.It was stated that one staff inserted the straight catheter in two patients, and it leaked both times.Per follow-up on (b)(6) 2021, it was reported that the catheter that leaked belonged to lot# ngewx143 and lot# ngfq0368.It was also reported that it looked like more than one lot# was leaking.It was unknown where the leak occurred.Per follow-up on 21jun21, it was stated that at least 6 leaking events have taken place as of last week.
Event or Problem Description
It was reported that straight catheter kits were leaking at the connection site to the drain bag.Per follow-up on 17jun21, it was reported that two staff had brought this forward.It was stated that one staff inserted the straight catheter in two patients, and it leaked both times.Per follow-up on 18jun21, it was reported that the catheter that leaked belonged to lot# ngewx143 and lot#ngfq0368.It was also reported that it looked like more than one lot# was leaking.It was unknown where the leak occurred.Per follow-up on 21jun21, it was stated that at least 6 leaking events have taken place as of last week.
Additional Manufacturer Narrative
The reported event was confirmed by capa association as design related issue.Per capa 3466686 / ucc-21-4267-sa, the investigation of root cause for leaks from the catheter where it connected to the drain bag will be documented in the capa upon completion.The investigation indicated that the reported issue was not manufacturing or supplier related.Therefore, a device history record review was not required.A risk review and labeling review is not required because the investigation was confirmed by the capa association.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

• Brand Name: SURESTEP INTERMITTENT CATHETER TRAY
• Common Device Name: INTERMITTENT CATHETER TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12164267
• Report Number: 1018233-2021-04186
• Device Sequence Number: 3988897
• Product Code: KOD
• UDI-Device Identifier: 00801741183232
• UDI-Public: (01)00801741183232
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K000723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2021

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 Expiration Date: 05/31/2022
• Device Model Number: INTS14C
• Device Catalogue Number: INTS14C
• Device Lot Number: NGEWX143
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 11/02/2021
• 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: Other