MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 22 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/09/2023

Event Type  Injury  

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 device has not been returned to the manufacturer for evaluation.

Event Description

It was reported that, clinican inserted the cannula into the r basilic vein which was quite deep on this particular pt (so cannula at a reasonable angle), the wire seemed to slide in ok.Clinician went to slide the midline in, the delivery device sort of buckled/fell apart and the line had not slid over the wire ¿ it had in fact concertina¿d and then the line and wire were stuck in pts arm.Clinician got surgeon to dissect down towards the vessel until he could remove them both.Clinician thought this was ¿me¿ eg angle too great, perhaps nearer to where tourniquet was.

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 complaint of device damage for a powerglide pro was confirmed.One 22 ga powerglide pro was returned for evaluation.An initial visual observation showed that the needle was bent and the safety was not activated.The safety was observed to be on the outside of the needle/guidewire housing.The device housing was returned intact with many of the components observed to be incorrectly positioned outside the housing.The guidewire appeared bent at the distal tip.The wings of the device were observed to be bent upwards as if they were pinched when compared to a non-complainant device.A microscopic observation revealed that the wings of the device had whitening and stress concentration points where the wings appeared to have been pinched together during use of the device.The coil wire of the guidewire was observed to be slightly unraveled at various points.It appears that the wings of the catheter carrier were pinched and bent upwards which allowed the catheter to become loose within the housing.This likely led to the reported difficulties during catheter insertion.The wings of the catheter carrier should be slid forward and not pinched or squeezed during advancement.

Event Description

It was reported that, clinician inserted the cannula into the r basilic vein which was quite deep on this particular pt (so cannula at a reasonable angle), the wire seemed to slide in ok.Clinician went to slide the midline in, the delivery device sort of buckled/fell apart and the line had not slid over the wire ¿ it had in fact concertina¿d and then the line and wire were stuck in pts arm.Clinician got surgeon to dissect down towards the vessel until he could remove them both.Clinician thought this was ¿me¿ eg angle too great, perhaps nearer to where tourniquet was.Additional information received 06/21/2023: it was reported by the customer "patient is fine - minor bruise only.".

• Brand Name: 22 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17224944
• MDR Text Key: 318088633
• Report Number: 3006260740-2023-02686
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 6F122080
• Device Lot Number: REGW1320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 09/07/2023
• Supplement Dates FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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