MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 AIRGUARD VALVED INTRODUCER, 16.5F; PORT AND CATHETER ACCESSORIES

Model Number	5513165
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a catheter placement procedure, saline allegedly leaked out of the system when syringe was attached to the blue end of the dilator lock.It was further reported that the saline allegedly squirted out of a small hole in the circular molding of the blue section.There was no patient contact.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiration date: 04/2023).Device not returned.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned for evaluation.However, four electronic photos were provided for review.The photo shows the partial view of the dilator.Therefore the investigation is inconclusive for the reported material puncture and fluid leak issues as there was no objective evidence obtained from the provided photos.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 04/2023).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.
Event or Problem Description
It was reported that prior to a catheter placement procedure, saline allegedly leaked out of the system when syringe was attached to the blue end of the dilator lock.It was further reported that the saline allegedly squirted out of a small hole in the circular molding of the blue section.There was no patient contact.

• Brand Name: AIRGUARD VALVED INTRODUCER, 16.5F
• 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: 16500840
• Report Number: 3006260740-2023-00713
• Device Sequence Number: 19671050
• Product Code: DYB
• UDI-Device Identifier: 00801741041600
• UDI-Public: (01)00801741041600
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

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 Model Number: 5513165
• Device Catalogue Number: 5513165
• Device Lot Number: REFU1587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2021
• 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