MAUDE Adverse Event Report: POWERLOC MAX POWER-INJECTIBLE 22G X 0.75"; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2021
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 asexf109 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported a patient returned to have their port de-accessed.The dressing appeared slightly damp and the cracked area was noted.The nurse tried to flush and there is a small hole that also leaks.No other information was provided.
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 a cracked y-site was confirmed and the root cause appeared to be supplier-related.The product returned for evaluation was two photographs depicting a non-valved infusion set y-site.What appeared to be a longitudinally aligned split was visible in both photographs.The split appeared to extend from the luer orifice nearly to the y joint.The threads appeared to be undamaged.The split occurred in a region consistent with fracture along a molding weld line produced by the molding process.The device is a supplied component and the supplier has been notified of this event.Evaluation findings are in section h.11.
Event or Problem Description
It was reported "three patients have returned to have their bottle of chemo and port de-accessed; dressings appeared slightly damp and the cracked area was then noted.Just prior to, the nurse tried to flush and there is a small hole that also leaks.".

• Brand Name: POWERLOC MAX POWER-INJECTIBLE 22G X 0.75"
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 11932017
• Report Number: 3006260740-2021-02138
• Device Sequence Number: 4491270
• Product Code: FPA
• UDI-Device Identifier: 00801741047404
• UDI-Public: (01)00801741047404
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K153440
• 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): 09/07/2021

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: 0132275
• Device Lot Number: ASEXF109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 09/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• 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