MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PG PRO 18G 10CM BASIC; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2021

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficult powerglide insertion was confirmed and the cause appeared to be manufacturing-related.The product returned for evaluation was four 18ga x 10cm powerglide pro midline catheter assemblies.All four samples were received fully assembled.Three samples appeared free of use residues.The fourth exhibited blood residue within the needle and catheter.Microscopic inspection of all four samples revealed irregular catheter tips.The irregular tips appeared to cause a rough transitions between the catheter tips and the needle shafts.The observed roughness between the catheter tips and the needle shafts would potentially result in resistance during attempted device insertion.The lack of use residues suggested that the catheter tip irregularities likely occurred during the catheter tipping process.Photographs of the sample have been forwarded to the manufacturing site for further evaluation.A lot history review (lhr) of refw4292 showed six other similar product complaint(s) from this lot number.

Event Description

It was reported "dullness of bard powerglide pro midline catheters".Additional information received via phone call: "we have to jab the patient very hard, and it will not go in the vein at all even if we are able to break skin.The plastic part of the catheter is flared." (b)(6) 2022: four samples were returned.All four samples exhibited the distal tip to be irregular.The irregular tip appeared to cause a rough transition between the catheter tip and the needle shaft.This report addresses the fourth device.

• Brand Name: PG PRO 18G 10CM BASIC
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13907551
• MDR Text Key: 288022299
• Report Number: 3006260740-2022-01001
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110511
• UDI-Public: (01)00801741110511
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F118100
• Device Lot Number: REFW4292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other