MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BASIC KIT 20G X 8 CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/07/2019
Type of Reportable Event	Serious Injury
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 a damaged guidewire was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph depicting a 20ga powerglide midline catheter assembly.Blood residue was observed throughout the catheter and safety mechanism.The catheter had been advanced and the safety mechanism was engaged over the needle tip.The guidewire advancer appeared fully advanced; however, the guidewire did not protrude from the needle tip.The advanced position of the advancer and lack of guidewire protruding from the needle indicated that either the guidewire had broken or was not engaged with the advancer.Inspection of the photograph was insufficient to confirm the precise nature of the wire damage and identify the cause of that damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include guidewire damage by retraction against the needle bevel and attempted guidewire insertion into tissue.A lot history review (lhr) of rect1271 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported rn used the ultrasound to confirm correct placement of powerglide needle tip in patient¿s right upper arm.When she dropped the ultrasound probe, she was able to deploy the guidewire smoothly.After feeling resistance when trying to deploy the catheter, rn then proceeded to pull the catheter back toward the device when she felt and heard a pop.After pulling the entire device out, the catheter was sheered towards the end and the guidewire was no longer attached to the powerglide.The tourniquet was left on patient¿s arm and the guidewire was confirmed in patients vein with xray.Patient was then taken to ir to have the guidewire successfully removed.
Additional Manufacturer Narrative
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 damaged guidewire was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph depicting a 20ga powerglide midline catheter assembly.Blood residue was observed throughout the catheter and safety mechanism.The catheter had been advanced and the safety mechanism was engaged over the needle tip.The guidewire advancer appeared fully advanced; however, the guidewire did not protrude from the needle tip.The advanced position of the advancer and lack of guidewire protruding from the needle indicated that either the guidewire had broken or was not engaged with the advancer.Inspection of the photograph was insufficient to confirm the precise nature of the wire damage and identify the cause of that damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include guidewire damage by retraction against the needle bevel and attempted guidewire insertion into tissue.A lot history review (lhr) of rect1271 showed no other similar product complaint(s) from this lot number.- attachment: [1380519-mw5087093.Pdf].
Event or Problem Description
It was reported rn used the ultrasound to confirm correct placement of powerglide needle tip in patient¿s right upper arm.When she dropped the ultrasound probe, she was able to deploy the guidewire smoothly.After feeling resistance when trying to deploy the catheter, rn then proceeded to pull the catheter back toward the device when she felt and heard a pop.After pulling the entire device out, the catheter was sheered towards the end and the guidewire was no longer attached to the powerglide.The tourniquet was left on patient¿s arm and the guidewire was confirmed in patients vein with xray.Patient was then taken to ir to have the guidewire successfully removed.6/17/2019- medwatch received stated, "midline catheter inserted in the right cephalic vessel under ultrasound guidance.Vessel accessed and guidewire advanced without resistance.As the catheter was advancing, resistance noted and catheter was pulled back and a popping sound was heard.Catheter was pulled out and noted that the wire was sheared and not intact.Stat x-ray revealed a 4 cm linear metal object within the anterolateral arm.Pt was transported to diagnostic imagine for retrieval of the wire foreign body.Retrieval was successful with no harm to the pt.".

• Brand Name: BASIC KIT 20G X 8 CM WITH BIOPATCH
• 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: 8658093
• Report Number: 3006260740-2019-01524
• Device Sequence Number: 1831168
• Product Code: FOZ
• UDI-Device Identifier: 00801741140525
• UDI-Public: (01)00801741140525
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019
• Report Date (Section F): 05/22/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: F320087T
• Device Lot Number: RECT1271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/07/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2019
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 05/22/2019