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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 0132075
Device Problems Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
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 device has not been returned, at this time, to the manufacturer for evaluation. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant. Device has not yet been returned for evaluation.
 
Event Description
It was reported that the port access needle cap fell off twice while patient was at home, once while the patient was in the shower and a second time when they were receiving an infusion in the middle of the night. The needle was replaced.
 
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 needle cap disconnecting was inconclusive due to unknown use conditions. The products returned for evaluation were two 20 ga x 0. 75 in w/y-site powerloc infusion sets. The samples were flushed with water using a 12 ml syringe and no leaks were observed. The luer taper gage was used to test the tapers and the proximal luers with the needleless injection caps attached were found to be out of specification. This is likely due to material creep caused by radiating stress within the luer hub orifice from over-tightening or use of slip fit attachments. As no leaks were observed when the connections were tightly secured and it is unknown how the connectors were secured at the time in which the alleged complaint occurred, the complaint is inconclusive due to unknown use conditions; however, the material creep may have been a contributing factor in the reported event. The product ifu states, "warnings: fully tighten all connections, y-site end caps, or needleless connectors before use. Failure to attach an end cap or appropriate needleless device after removing a male luer locking cap or needleless connector can result in an embolism or bleeding. " this report addresses sample 1. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported that the port access needle cap fell off twice while patient was at home, once while the patient was in the shower and a second time when they were receiving an infusion in the middle of the night. The needle was replaced.
 
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Brand NamePOWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer Contact
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key7584438
MDR Text Key110801025
Report Number3006260740-2018-01309
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00801741047374
UDI-Public(01)00801741047374
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153440
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0132075
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Home
Date Manufacturer Received07/03/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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