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	06/16/2021
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.The device was not returned.
Event or Problem Description
It was reported that the straight catheter kits were leaking at the connection site to the drain bag.Per follow up on 17jun2021 it was stated that two staff members had brought this forward.It was stated that one staff inserted the straight catheter in two patients and it leaked both the times.Per follow up on 18jun2021 it was stated that the catheter that leaked belonged to lot ngewx143 and lot#ngfq0368.It was also reported that it looks like more than one lot was leaking.It was unknown where the leakage was occurring.Per follow up on 21jun2021 it was stated that at least 6 leaking events have taken place as of last week.
Event or Problem Description
It was reported that the straight catheter kits were leaking at the connection site to the drain bag.Per follow up on (b)(6) 2021 it was stated that two staff members had brought this forward.It was stated that one staff inserted the straight catheter in two patients and it leaked both the times.Per follow up on (b)(6) 2021 it was stated that the catheter that leaked belonged to lot ngewx143 and lot#ngfq0368.It was also reported that it looks like more than one lot was leaking.It was unknown where the leakage was occurring.Per follow up on (b)(2021 it was stated that at least 6 leaking events have taken place as of last week.
Additional Manufacturer Narrative
The reported event was inconclusive.It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.No sample was returned for evaluation.A potential root cause for this failure could be due to "incorrect assembly operation".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "indications for use: pvc & red rubber: for urological use only silicone: intended for use for bladder management including urine drainage, collection and measurement.The devices are generally passed to the urinary bladder via the urethra.1.Wash hands and don clean gloves 3.Use the provided packet of wipes to cleanse patient¿s periurethral area 2.Explain procedure to patient and open peri-care kit 4.Remove gloves and perform hand hygiene with provided alcohol hand sanitizer gel 7.Place underpad beneath patient, plastic/¿shiny¿ side down 6.Don sterile gloves 8.Position fenestrated drape on patient 10.Lubricate catheter 12.Proceed with catheterization in usual manner using the dominant hand a.When catheter tip has entered bladder, urine will be visible in the drainage tube 13.Document procedure according to hospital protocol 11.Prepare patient with 3 foam swab sticks saturated in povidone iodine.Use the nondominant hand for the genitalia and the dominant hand for the swabs 5.Using proper aseptic technique open csr wrap 9.Saturate 3 foam swab sticks in povidone iodine" 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: CATHETER TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12127721
• Report Number: 1018233-2021-04060
• Device Sequence Number: 14559113
• 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): Y
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021

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: 02/28/2022
• Device Model Number: INTS14C
• Device Catalogue Number: INTS14C
• Device Lot Number: NGFQ0368
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 09/27/2021
• 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