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

Model Number	N/A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of reby0507 showed no other similar product complaint(s) from this lot number.Device not received.
Event or Problem Description
It was reported that the needle was advanced into vein with ultrasound guidance.Wire advanced without difficulty, and then catheter advanced without difficulty.Once catheter fully advanced to skin, user allegedly noted difficulty removing casing from the back of the device.Reportedly, resistance was met upon retraction, so attempted to retract housing with catheter as one unit.User was apparently able to remove the housing, but noticed that catheter had allegedly sheared completely in half, close to the hub of the catheter.Tourniquet was immediately applied to arm, and physician notified.Upon further inspection, noted that remaining catheter could be observed in subcutaneous tissue, and was removed.Once removed, catheter allegedly looked visibly damaged.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a damaged powerglide catheter 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 received separated from the assembly.The safety mechanism was engaged over the needle tip.The catheter was received in two segments which appeared to share a complete break near the molded joint.The distal catheter fragment exhibited abundant deformation.The guidewire exhibited curved shape memory.The weld tip was intact.Microscopic inspection of the catheter fracture surface revealed regions of glossy striations.The proximal fracture surface exhibited abundant deformation.Inspection of the guidewire revealed several displaced coils along much of the coil/core region.The needle bevel exhibited deformation and pitting along the proximal edge.The extensive catheter and guidewire deformation were consistent with attempted device insertion against resistance.The needle bevel damage was consistent with guidewire withdrawal against the needle.The catheter fracture features were consistent with catheter damage initiated by contact with a sharp instrument, such as the introducer needle bevel.Combined, these observations suggest that insertion was initially attempted against resistance and subsequently, the wire and catheter were both withdrawn against the needle bevel.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.¿.
Event or Problem Description
It was reported that the needle was advanced into vein with ultrasound guidance.Wire advanced without difficulty, and then catheter advanced without difficulty.Once catheter fully advanced to skin, user allegedly noted difficulty removing casing from the back of the device.Reportedly, resistance was met upon retraction, so attempted to retract housing with catheter as one unit.User was apparently able to remove the housing, but noticed that catheter had allegedly sheared completely in half, close to the hub of the catheter.Tourniquet was immediately applied to arm, and physician notified.Upon further inspection, noted that remaining catheter could be observed in subcutaneous tissue, and was removed.Once removed, catheter allegedly looked visibly damaged.

• Brand Name: PG PRO 22G 8CM BASIC KIT
• 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: 8005035
• Report Number: 3006260740-2018-03035
• Device Sequence Number: 1190401
• Product Code: FOZ
• UDI-Device Identifier: 00801741110542
• UDI-Public: (01)00801741110542
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K153280
• 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): 12/17/2018

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 Model Number: N/A
• Device Catalogue Number: F122080
• Device Lot Number: REBY0507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 12/17/2018
• 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