MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 22G X 8 CM WITH PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Material Frayed (1262)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/31/2021

Event Type  Injury  

Event Description

It was reported by health professional "powerglide guidewire did not retract properly.It remained in the catheter when they pulled out.They said the guidewire snapped off from the powerglide body and remained in the catheter." no other information was provided.

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

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, 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 placement/device damage was confirmed; however, the root cause was not identified.The product returned for evaluation was three photographs depicting a 22ga x 8cm powerglide pro midline catheter assembly.The catheter had been advanced and the safety mechanism was engaged over the needle tip.The first two photographs depicted the housing and needle shaft.The needle shaft appeared to be bent.The guidewire advancer was advanced; however, the guidewire was not visible past the safety mechanism.The third photograph depicted the advanced catheter.Blood residue was evident within the catheter shaft.Multiple bends and kinks were observed along the catheter shaft.The advanced state of the guidewire and the inability to observe the guidewire past the safety suggested that the guidewire as broken, as indicated in the event description.The bent needle and deformed catheter were consistent with attempted insertion against resistance, and guidewire damage can occur if the wire is retracted against the needle following such insertion resistance; however, an additional factor(s) may have contributed, but could not be identified through inspection of the submitted photographs.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported by health professional "powerglide guidewire did not retract properly.It remained in the catheter when they pulled out.They said the guidewire snapped off from the powerglide body and remained in the catheter." no other information was provided.

• Brand Name: FULL KIT 22G X 8 CM WITH PROBE COVER
• 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: 12861979
• MDR Text Key: 281156778
• Report Number: 3006260740-2021-04975
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140648
• UDI-Public: (01)00801741140648
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162377
• 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,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F222088PT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention