MAUDE Adverse Event Report: FULL KIT 18G X 8 CM WITH BIOPATCH AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
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 refp1919 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "upon what appeared to be a routine, straightforward insertion, the needle did not safety properly.No patient harm, no clinician harm, catheter placed successfully and functioning properly.".
Event or Problem Description
It was reported "upon what appeared to be a routine, straightforward insertion, the needle did not safety properly.No patient harm, no clinician harm, catheter placed successfully and functioning properly.".
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.One powerglide pro deployment system was returned for investigation without the catheter.The safety mechanism was received separate from the needle and was full of what appeared to be dry blood.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, which would allow the safety mechanism to separate from the needle.A portion of the o-ring cross section exhibited a glossy and striated surface, which is consistent with sharp instrument damage.A nick in the o-ring appeared to be a contributing factor in the material break.The cause of the nick is unknown, but may have been attributable to compression of the material against a sharp edge of the device.No damage was observed on the other components within the safety mechanism.Whether the damage occurred at the time the safety mechanism was activated could not be determined and the observations of the returned sample and a review of the manufacturing records do not point to a specific root cause.H3 other text : evaluation findings are in section h.11.

• Brand Name: FULL KIT 18G X 8 CM WITH BIOPATCH AND PROBE COVER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• MDR Report Key: 11971246
• Report Number: 3006260740-2021-02248
• Device Sequence Number: 17204139
• Product Code: FOZ
• UDI-Device Identifier: 00801741140655
• UDI-Public: (01)00801741140655
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 08/03/2021

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: N/A
• Device Catalogue Number: F318088PT
• Device Lot Number: REFP1919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 08/23/2021
• 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