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
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refw1235 showed no other similar product complaint(s) from this lot number.
Event or Problem 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".
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 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.
Event or Problem 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".10/10/2022 - four samples were returned for evaluation.This report addresses the first device.

• Brand Name: PG PRO 18G 10CM BASIC
• Common Device Name: 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: 13979784
• Report Number: 3006260740-2022-01113
• Device Sequence Number: 17496116
• Product Code: FOZ
• UDI-Device Identifier: 00801741110511
• UDI-Public: (01)00801741110511
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2022

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F118100
• Device Lot Number: REFW1235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown