MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 IMAGING ACCESSORIES, KIT, NEEDLE GUIDE KIT W/ PROBE COVER, N/A

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The complaint of plastic shavings inside needle guides is confirmed, but the root cause could not be determined.Three 21 ga needle guide sets were returned for evaluation.An initial visual observation of each returned kit revealed the 1.0 cm needle guides for each set had some uneven plastic.Use residues were observed along the needle guides.Sample 1 was missing the 2.0 cm needle guide.A microscopic observation revealed plastic shavings inside the 1.0 cm needle guide of each of the three returned kits.Plastic shavings were observed inside the 2.0 cm needle guide of sample kit 3.Blood use residues were observed throughout sample 1 and on the cardboard of sample 3.A functional test of attempting to slide a 21 ga introducer needle through each of the eight individual needle guides returned in the three kits revealed a 21 ga introducer needle could pass through each needle guide.Functional testing of the needle guides in sample 3 revealed some resistance during use of the 1.0 cm needle guide and the 2.0 cm needle guide with some of the internal plastic falling out of the devices.Functional testing was performed after an initial microscopic observation of each returned device.Because these products were returned used, it could not be determined whether the failure occurred during use or before use of the products.The needle bevel may cause damage to the inside of the needle guide if the insertion of the needle is incorrect.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by the customer can pull needle through the needle guide.It was reported this occurred with three devices.This report addresses all three devices.On 06/10/2025 - during evaluation of the three returned devices, pieces of plastic were noted in the devices.

• Brand Name: IMAGING ACCESSORIES, KIT, NEEDLE GUIDE KIT W/ PROBE COVER, N/A
• Common Device Name: IMAGING ACCESSORIES, KIT, NEEDLE GUIDE KIT W/ PROBE COVER, N/A
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22342676
• Report Number: 3006260740-2025-04335
• Device Sequence Number: 4825723
• Product Code: ITX
• UDI-Device Identifier: 00801741037771
• UDI-Public: (01)00801741037771(11)240706(17)270430(10)REJS2466
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K042445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2025

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 Model Number: N/A
• Device Catalogue Number: 900013B01
• Device Lot Number: REJS2466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown