MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	0141975
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of ascps0200 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by a health professional that the patient was accessed with a huber 0.75 inch power port needle.He stated, "i twisted the blue leur lock connector on the end it would not tighten down.I tried another blue connector and it would still not tighten up and seal properly.I then tried those blue connectors on the end of a different huber needle and it tightened just fine." no patient injury reported.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency 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 damaged connector was confirmed and the cause appears to be use related.The product returned for evaluation was a 19 ga x 0.75 in powerloc max.The investigation findings are consistent with damage accumulated through gradual deformation due to continuous outward-radiating stress within the luer hub orifice, also known as material creep.Likely sources of the stress include slip-fit style male luer adapters such as those found on some i.V.Administration sets and syringes.The returned product sample was evaluated and the characteristics observed which supported this type of failure included: the luer hub orifice was found to be out of iso tolerance using a calibrated taper gauge.Lack of mechanical damage on the luer hub.A non-complainant slip-fit luer device was returned which implied the use of this type of device.Leakage from the luer hub was confirmed during infusion testing the evidence suggests that a tapered object was forcefully inserted into the luer hub orifice then left in place, resulting in gradual widening, or creep, of the luer hub material.This type of failure was replicated at bas using 5 iso compliant slip-fit adapters and 5 non-complainant infusion sets.A combination of use of slip-fit style adapters, the force with which those adapters were inserted, and the duration of insertion resulted in this type of slow luer hub deformation.Creep deformation takes place over days; however, the rate of deformation depends upon the force used to insert the taper.This type of damage may possibly be mitigated by reducing the insertion force and/or using luer-lock style adapters.A lot history review (lhr) of ascps0200 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by a health professional that the patient was accessed with a huber 0.75 inch power port needle.He stated, "i twisted the blue luer lock connector on the end it would not tighten down.I tried another blue connector and it would still not tighten up and seal properly.I then tried those blue connectors on the end of a different huber needle and it tightened just fine." no patient injury reported.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 0.75IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7500812
• Report Number: 3006260740-2018-00943
• Device Sequence Number: 19285871
• Product Code: FPA
• UDI-Device Identifier: 00801741047435
• UDI-Public: (01)00801741047435
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2018

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 Catalogue Number: 0141975
• Device Lot Number: ASCPS0200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1