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	Hematoma (1884)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported 2 instances of catheters having blunt tips leading bending and failure of placing line.Add info rcvd (b)(6) 2021: none of the hematomas required surgical intervention.Placement info: dull tip, unable to place.Was there patient harm reported?: hematoma at site.What they¿re being treated for: hemolytic uremic syndrome.Medwatch mw5103282 rcvd (b)(6) 2021: bard midline 18g powerglide pro, blunt end, 2 failed attempts due to defect of blunt tip to catheter, successful 3rd attempt.(b)(6) 2021: one sample was returned to the manufacturer.The returned sample exhibited an outward flaring catheter tip.
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 one 18ga x 10cm powerglide pro midline catheter assembly.The sample was received fully assembled.The guidewire was fully advanced and the catheter was slightly advanced.Blood residue was observed on the wire and within the catheter.Microscopic inspection of the distal end of the catheter revealed it to appear irregular.Gaps were observed between the needle shaft and the catheter tip.The catheter tip appeared to be slightly flared away from the needle.The rough transition between the catheter and the needle shaft would likely have resulted in resistance when attempting to insert the catheter.That rough transition appeared to be caused by the irregular and outward flaring catheter tip, potentially caused during the catheter tipping process.Photographs have been forwarded to the manufacturing site for further evaluation.Based on evaluation of the photographs by the manufacturing site, the precise root cause could not be identified.Consequently this complaint is confirmed as 'cause unknown' at this time.A lot history review (lhr) of reeu2440 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reeu2440) have been reported from the same facility.

• 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: 12804881
• Report Number: 3006260740-2021-04843
• Device Sequence Number: 5575884
• Product Code: FOZ
• UDI-Device Identifier: 00801741110511
• UDI-Public: (01)00801741110511
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/30/2021

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: REEU2440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2020
• 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 Age: 14 YR
• Patient Sex: Female