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 03/09/2022

Event Type  malfunction  

Event Description

It was reported "catheter is "fish mouthing" on insertion and preventing the catheter from being inserted into the vein.The catheter material softens on insertion and causing the catheter tip to widen "fish mouth".Four devices were returned for evaluation.This report addresses the second device.

Manufacturer Narrative

The following were reviewed as part of this investigation:¿patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.¿ based on a review of this information, the following was concluded: the complaint of defective powerglide pro devices was confirmed.Four 18 ga x 10 cm powerglide pro devices were returned for evaluation.The devices were returned with their needle covers and catheters present over the needles.The first two samples contained blood residue over the needle, catheter, and housing.The guidewires on the first two samples were also found to be bunched within the housing.The third and fourth samples did not appear to contain blood residue and no apparent issues with the guidewire were noted.Both the needle bevel and the distal catheter tip were microscopically inspected on each returned sample.The edges of the catheter tip were observed to be somewhat rough and appeared to contain a slight bulge in the material.The characteristics of the catheter tips are consistent with the samples containing blood residue and the samples which appear to be unused.The rough edges in the catheter transition tip are a likely contributing factor to a difficult insertion; therefore, the complaint is confirmed.Bd is working closely with the manufacturing facility to prevent reoccurrence of the reported event.A lot history review (lhr) of refw1235 showed three other similar product complaint(s) from this lot number.The complaints for this lot number (refw1235) were reported from the same facility.

• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15601644
• MDR Text Key: 305998197
• Report Number: 3006260740-2022-04003
• 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: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• 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: REFW1235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2022
• 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