MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PICC, REPAIR KITS; PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer, after the completion of the puncture, the tube placement hand installs the decompression sleeve and installs the connector, after the installation, the tube placement hand looks at the connector with a gap and pulls the connector with a little force to separate it, so the catheter is re-replaced and replaced with a new connector.
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 manufacturer has received the sample and it will be evaluated.A supplemental will be submitted with evaluation results.
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 a groshong connector disconnecting is confirmed and was determined to be related to manufacture of the device.One 4 fr two-piece groshong nxt clearvue connector was returned for evaluation.One photograph of a 4 fr groshong two-piece connector was returned for evaluation.An initial visual observation revealed use residues were observed along the returned two-piece connector.The connector was returned assembled with no catheter inside the device.A functional test of attempting to pull the distal connector off the proximal connector revealed the distal connector disconnected with little force.A microscopic observation revealed deformation was observed along the molded section of the proximal connector.Measurement of the proximal connector arms revealed them to be.140 in.Apart, which is out of specifications.Because the proximal connector arms were measured to be outside of drawing specifications, the complaint of the connector disconnecting is confirmed and was determined to be related to the manufacture of the product.Awareness training has been conducted as part of this complaint and this complaint will be recorded for future trending and monitoring purposes.

• Brand Name: PICC, REPAIR KITS
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)
• 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: 21328123
• Report Number: 3006260740-2025-00416
• Device Sequence Number: 15574514
• Product Code: LJS
• UDI-Device Identifier: 00801741075261
• UDI-Public: (01)00801741075261(11)220623(17)270228(10)REGQ2337
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K034020
• 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,Followup
• Report Date (Section B): 06/19/2025

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: 7812400
• Device Lot Number: REGQ2337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 06/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2022
• 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