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	11/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "pg feel dull and won't puncture skin." (b)(6) 2022-three devices were returned for evaluation.Each device exhibited rough/split transitions between the catheter tips and needle shafts.This report addresses the second device.
Additional 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 catheter insertion was confirmed; however, the root cause was not identified.The product returned for evaluation was three 18ga x 10cm powerglide pro midline catheter assemblies.The product returned for evaluation was three 18ga x 10cm powerglide pro midline catheter assemblies.The first sample (sample exhibited use residues throughout.The catheter was advanced and the safety mechanism was engaged.The catheter shaft exhibited curved shape memory.A split was observed in the catheter shaft near the distal tip.Microscopic inspection of sample 1 revealed deformation of the distal tip.Inspection of the split revealed a partially glossy fracture surface consistent with perforation by the introducer needle tip.The second sample (sample 2) was received fully assembled.Blood residue was observed within the catheter shaft.The third sample (sample 3) was received fully assembled and appeared free of obvious use residues.Microscopic inspection of samples 2 and 3 revealed irregular catheter tips.The transitions between the catheter tips and needle shafts were rough.The rough transitions would likely result in resistance when attempting to advance the catheters.The rough transitions appeared to be caused either by irregular catheter tip formation during the catheter tipping process or subsequent tip damage.Photographs have been forwarded to the manufacturing site for further evaluation.A lot history review (lhr) of refw1235 showed three other similar product complaint(s) from this lot number.Evaluation findings.

• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13595696
• Report Number: 3006260740-2022-00444
• Device Sequence Number: 20297864
• Product Code: FOZ
• UDI-Device Identifier: 00801741110511
• UDI-Public: (01)00801741110511
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 02/24/2022

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
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 02/24/2022
• 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