MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 AIRGUARD VALVED INTRODUCER, 8F; PORT AND CATHETER ACCESSORIES

Catalog Number	5515180
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 prior to a port placement procedure, the rip/hole was allegedly found in the packaging by compromising sterility.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: one sealed 8.0 airguard peel-apart sheath and vessel dilator were received for evaluation.Visual evaluation was performed on the returned device.The sealed package was inspected thoroughly.Small holes were noted on the clear side of the sealed package.Components did not appear affected.No other anomalies were noted.The manufacturing site evaluation states, an initial view showed a sealed airguard kit, the ifu was observed inside the packaging, a tear was observed in the transparent part of the pouch near the supplier's seal, the components inside did not appear to be affected.A closer look at the additional images provided by field assurance showed two small holes in the packaging, the id of the holes were 0.4146mm and 0.7398mm, no other anomalies were observed throughout the sample.Therefore the investigation is confirmed for the reported tears, rips or hole in device packaging.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3, h4, h6 (method, component).H11: d4 (unique identifier (udi) #), h6 (result, conclusion).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 prior to a port placement procedure, the rip/hole was allegedly found in the packaging by compromising sterility.There was no patient contact.

• Brand Name: AIRGUARD VALVED INTRODUCER, 8F
• Common Device Name: PORT AND CATHETER ACCESSORIES
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 21442739
• Report Number: 3006260740-2025-00923
• Device Sequence Number: 12703126
• Product Code: DYB
• UDI-Device Identifier: 00801741041631
• UDI-Public: (01)00801741041631(11)241121(17)260731(10)REJX1056
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 5515180
• Device Lot Number: REJX1056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 02/23/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2024
• 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
• Patient Sex: Unknown