MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BASIC KIT 22G X 8 CM WITH GUARDIVA; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redu0645 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "i was placing a powerglide pro on friday.I advanced the guidewire and then the catheter.However the safety did not fully engage and then there was resistance when attempting to remove the needle and guidewire.I increased by pressure and felt a sudden pop and release of pressure.At that point the guidewire did not seem to be the correct length, i attempted to aspirate blood but that was not successful.Decision was made to remove the catheter.Once removed it appeared on us that part of the catheter or guidewire remained in the patient.Arm and chest x-rays obtained stat, no catheter fragment identified.Further investigation revealed guidewire piece retained in the catheter." additional information rcvd 06/11/2020 - midline placed under sterile conditions with ultrasound.Vessel punctured and needle advanced to be seated in the vessel.Guidewire advanced within the vessel and fully engaged.Catheter slid of the needle and over the guidewire without issue.As i attempted to pull the needle and guidewire all the way out of the catheter resistance was met.An assistant applied sterile gloves to assist, in an effort to save the line another attempt was made to remove the needle and guidewire.Resistance was met again and then a sudden loss of resistance and a pop was felt.The needle and guidewire were removed.The needle safety did not engage properly, so i manually engaged the safety.An iv extension with syringe was attached and attempted to aspirate blood.Inspection of the device lead to concern the guidewire was not the appropriate length and potentially broke.Decision was made to remove the catheter and it appear that a piece of guidewire was retained in the catheter.The patients vessel was review with ultrasound and there was a concern that either a piece of catheter or guidewire remained in the patient.The patient required stat portable upper extremity xray and chest xray to verify no catheter or guidewire fragments remained.
Additional 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 a broken accucath guidewire was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 22ga x 8cm 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 extension set was attached to the catheter luer adapter.A complete break was observed in the guidewire within the coil/core region.The distal guidewire fragment, including the weld tip, was found within the catheter.Microscopic inspection of the distal guidewire fragment confirmed that the weld tip was intact.Abundant bunching and buckling of the coil wire were observed.Inspection of the break revealed a granular fracture surface.Necking was observed in the vicinity of the break.Inspection of the needle bevel revealed mechanical damage along the proximal edge.A kink was observed in the catheter shaft just distal of the molded joint.Microscopic inspection of the catheter revealed deformation at the distal tip.Inspection of the kink site revealed discoloration, buckling, and a tear at the corner of the kink.The catheter damage and abundant coil wire buckling were consistent with damage caused by attempted advancement against resistance, such as into tissue.The needle bevel damage was consistent with wire retraction against the needle bevel and the break in the core wire was consistent with material failure due to tensile (pulling) stress.Collectively, these observations suggest that insertion was initially attempted against resistance, causing component damage sufficient to result in wire breakage during device removal.A lot history review (lhr) of redu0645 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "i was placing a powerglide pro on friday.I advanced the guidewire and then the catheter.However the safety did not fully engage and then there was resistance when attempting to remove the needle and guidewire.I increased by pressure and felt a sudden pop and release of pressure.At that point the guidewire did not seem to be the correct length, i attempted to aspirate blood but that was not successful.Decision was made to remove the catheter.Once removed it appeared on us that part of the catheter or guidewire remained in the patient.Arm and chest x-rays obtained stat, no catheter fragment identified.Further investigation revealed guidewire piece retained in the catheter." additional information rcvd 06/11/2020 - midline placed under sterile conditions with ultrasound.Vessel punctured and needle advanced to be seated in the vessel.Guidewire advanced within the vessel and fully engaged.Catheter slid of the needle and over the guidewire without issue.As i attempted to pull the needle and guidewire all the way out of the catheter resistance was met.An assistant applied sterile gloves to assist, in an effort to save the line another attempt was made to remove the needle and guidewire.Resistance was met again and then a sudden loss of resistance and a pop was felt.The needle and guidewire were removed.The needle safety did not engage properly, so i manually engaged the safety.An iv extension with syringe was attached and attempted to aspirate blood.Inspection of the device lead to concern the guidewire was not the appropriate length and potentially broke.Decision was made to remove the catheter and it appear that a piece of guidewire was retained in the catheter.The patients vessel was review with ultrasound and there was a concern that either a piece of catheter or guidewire remained in the patient.The patient required stat portable upper extremity xray and chest xray to verify no catheter or guidewire fragments remained.

• Brand Name: BASIC KIT 22G X 8 CM WITH GUARDIVA
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10217464
• Report Number: 3006260740-2020-02296
• Device Sequence Number: 3500129
• Product Code: FOZ
• UDI-Device Identifier: 00801741140495
• UDI-Public: (01)00801741140495
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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 Expiration Date: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: F122087T
• Device Lot Number: REDU0645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Weight: 28