MAUDE Adverse Event Report: BASIC KIT 18G X 10 CM WITH GUARDIVA; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	F118107T
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refq4597 showed no similar product complaint(s) from this lot number.
Event or Problem Description
It was reported powerglide needle tip was left exposed.No patient harm reported.Additional info.Received 07/19/2021 " when placing a 10cm powerglide midline, venous access was obtained, the wire easily thread into vein, and catheter easily slid over guidewire into patient¿s vessel.However, when removing [very gently] the remainder of the catheter from the green wings, the needle housing device remained connected to the green wings and did not stay on the needle; therefore, the needle tip was left exposed and was a hazard/sharp.No patient harm occurred.Line was salvageable.".
Event or Problem Description
It was reported powerglide needle tip was left exposed.No patient harm reported.Additional info.Received 07/19/2021 " when placing a 10cm powerglide midline, venous access was obtained, the wire easily thread into vein, and catheter easily slid over guidewire into patient¿s vessel.However, when removing [very gently] the remainder of the catheter from the green wings, the needle housing device remained connected to the green wings and did not stay on the needle; therefore, the needle tip was left exposed and was a hazard/sharp.No patient harm occurred.Line was salvageable.".
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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint that the safety mechanism separated from the needle was confirmed, but the exact mechanism of damage was undetermined.The safety mechanism and green wings from a powerglide pro deployment system were the only items returned for investigation.The stem at the distal end of the safety mechanism was still attached to the plug on the green wings.The safety mechanism was full of what appeared to be dry blood.When the safety mechanism was disassembled, it was noted that the o-ring was not in the correct position within the safety mechanism.A microscopic examination of the safety mechanism revealed a break in the o-ring.A portion of the o-ring cross section exhibited a glossy surface.The remainder of the surface was dull and uneven.No damage was observed on the other components.The cause of the break in the o-ring is unknown, but the break allowed the safety mechanism to separate from the needle.It could not be determined when or how the material was damaged.A review of the manufacturing records showed no evidence that the reported event was caused by the manufacturing process.H3 other text : evaluation findings are in section h.11.

• Brand Name: BASIC KIT 18G X 10 CM WITH GUARDIVA
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 12281153
• Report Number: 3006260740-2021-03168
• Device Sequence Number: 11885827
• Product Code: FOZ
• UDI-Device Identifier: 00801741140464
• UDI-Public: (01)00801741140464
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

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 Model Number: F118107T
• Device Catalogue Number: F118107T
• Device Lot Number: REFQ4597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 09/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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