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

Catalog Number	INTP14
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that customer have noticed a weird packaging pattern with the new intermittent catheter kits.When opening the kit, the catheter tip tends to be outside of the white container and very close to the corner of the sterile drape.They just wanted to point this out because it seems odd and may result in contamination if not careful.Per additional information received on 03sep2025, the concern was the catheter tip was very close the edge of the sterile field and this has caused several kits to be thrown out because of the sterility concern of the catheter tip.That has been discovered in different size kits and different lots.It was not the same in every kit being opened so they were not sure what was going on.They switched to these kits to help reduce cautions and this concerns us that they could potentially see an increase.Per additional information received on 05sep2025, it was reported that the customer has 6 lot numbers impacted and have noticed it was not every kit in every lot.Considering it was 2 pavilion units, periop spaces & hup main cdr, they would say the impact was hospital wide.They mentioned the lot number and product as below: 6fr: pedints06 would lot pk7648761, 16fr: intl16 with lot pk7648761 and 14fr: intp14: lot #'s ngks1201, ngkr4485, ngkr4499, ngkq1877.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all 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.
Event or Problem Description
It was reported that customer have noticed a weird packaging pattern with the new intermittent catheter kits.When opening the kit, the catheter tip tends to be outside of the white container and very close to the corner of the sterile drape.They just wanted to point this out because it seems odd and may result in contamination if not careful.Per additional information received on 03sep2025, the concern was the catheter tip was very close the edge of the sterile field and this has caused several kits to be thrown out because of the sterility concern of the catheter tip.That has been discovered in different size kits and different lots.It was not the same in every kit being opened so they were not sure what was going on.They switched to these kits to help reduce cautions and this concerns us that they could potentially see an increase.Per additional information received on 05sep2025, it was reported that the customer has 6 lot numbers impacted and have noticed it was not every kit in every lot.Considering it was 2 pavilion units, periop spaces & hup main cdr, they would say the impact was hospital wide.They mentioned the lot number and product as below: 6fr: pedints06 would lot pk7648761, 16fr: intl16 with lot pk7648761 and 14fr: intp14: lot #'s ngks1201, ngkr4485, ngkr4499, ngkq1877.Per additional information received on 11sept2025, the additional lot #ngkp4108 has been provided.Per additional information received via email on 19sept2025, it was reported that they noticed the issue prior to being used on a patient.No patient impact and medical intervention was reported.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned two-photo sample and one video sample noted one opened (with original packaging), pedints06 surestep intermittent catheter tray.Visual inspection of the sample noted the catheter tip outside the sterile drape of the package.Instructions for use were reviewed for this investigation.The labeling is found to be adequate.A review of the device history records did not show any problems or conditions that would have contributed to the reported issue.Correction: d, h.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all 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.

• 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 GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 23063333
• Report Number: 1018233-2025-08138
• Device Sequence Number: 9671060
• Product Code: KOD
• UDI-Device Identifier: 00801741183294
• UDI-Public: (01)00801741183294(11)250604(17)270930(10)NGKR4485
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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: INTP14
• Device Lot Number: NGKR4485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown