MAUDE Adverse Event Report: FULL KIT 22G X 8 CM WITH BIOPATCH AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	F322088PT
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reep4109 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported had trouble retracting the device, it did safety, but the clinician felt like it got stuck on the green clips during insertion and retraction.(b)(6) 2021 -the returned sample has a perforated catheter.
Event or Problem Description
It was reported had trouble retracting the device, it did safety, but the clinician felt like it got stuck on the green clips during insertion and retraction.On (b)(6) 2021 -the returned sample has a perforated catheter.
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 powerglide pro placement complications was confirmed.The product returned for evaluation was one 22ga x 8cm powerglide pro midline catheter assembly.Usage residues were observed throughout the sample.The catheter had been advanced and was received separated from the assembly.The safety mechanism was not advanced over the needle tip.The safety remained engaged with the catheter advancer, which was separated from the catheter.Dried blood was observed within the safety cannister.An irregular longitudinally aligned split was observed in the catheter shaft.Microscopic inspection of the split revealed sharply defined, irregular edges.Material flow toward the catheter tip was observed in the vicinity of the split.An attempt activate the safety mechanism was unsuccessful.It appeared that the dried blood within the safety prevented proper binding with the needle.The safety mechanism failure appeared to be caused by allowing blood products to dry within the cannister prior to safety activation.The curved shape memory exhibited by both the catheter and guidewire suggested that insertion against resistance may have occurred.The catheter split features were consistent with damage caused by retraction of the catheter against the needle tip.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.¿ h3 other text : evaluation findings are in section h.11.

• Brand Name: FULL KIT 22G X 8 CM WITH BIOPATCH AND PROBE COVER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 11531531
• Report Number: 3006260740-2021-00902
• Device Sequence Number: 4091683
• Product Code: FOZ
• UDI-Device Identifier: 00801741140693
• UDI-Public: (01)00801741140693
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2021

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: 04/30/2021
• Device Model Number: F322088PT
• Device Catalogue Number: F322088PT
• Device Lot Number: REEP4109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 08/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other