MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 10 CM WITH PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/04/2021

Event Type  Injury  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reft2323 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "power glide 7cm shear off and is stuck in the patients arm".Additional info.Received 10/06/2021 ¿the patient was transferred to another hospital facility under a surgical consult.She underwent several imaging studies inclusive of arm venogram, and cta of chest abdomen and pelvis.Unable to locate catheter at present.".

Event Description

It was reported "power glide 7cm shear off and is stuck in the patients arm" additional info.Received 10/06/2021 ¿the patient was transferred to another hospital facility under a surgical consult.She underwent several imaging studies inclusive of arm venogram, and cta of chest abdomen and pelvis.Unable to locate catheter at present.".

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 the catheter being perforated by the needle and the guidewire being bent was confirmed.The product returned for evaluation was one 20ga x 10cm powerglide pro midline catheter assembly.Usage residues were observed throughout the sample.The catheter was advanced and the safety mechanism was engaged over the needle tip.The guidewire exhibited curved shape memory but was intact.The needle shaft was bent.The catheter terminated 2.9cm from the molded joint.The break exhibited a tapered cross section.Microscopic inspection of the split in the catheter revealed a glossy fracture surface.A longitudinally aligned scoring mark was observed on the inside surface of the catheter leading into the fracture surface.The catheter break was consistent with damage caused by contact with the tip of the introducer needle.The guidewire curved shape memory and needle shaft bend were consistent with damage caused by attempted insertion/advancement against resistance, such as into tissue.It appeared that initial resistance was encountered during attempted device placement, followed by catheter withdrawal onto the introducer needle.The product ifu states ¿warning: once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter.¿ device evaluation findings are in the manufacturer's note.

• Brand Name: FULL KIT 20G X 10 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: 12707938
• MDR Text Key: 278764538
• Report Number: 3006260740-2021-04596
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140631
• UDI-Public: (01)00801741140631
• 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: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• 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: F220108PT
• Device Lot Number: REFT2323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2021
• 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
• Patient Age: 25 YR
• Patient Sex: Female