MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 19G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2020
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 asdrf078 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported rn accessed patient with a 19g 3/4in power loc mediport needle.Lot number asdrf078.On initial flush it starting leaking from y-site connection.When rn checked it, the tubing disconnected from y-site area.Rn was still sterile.Re-accessed with another power loc mediport without issue.
Event or Problem Description
It was reported rn accessed patient with a 19g 3/4in power loc mediport needle.Lot number asdrf078.On initial flush it starting leaking from y-site connection.When rn checked it, the tubing disconnected from y-site area.Rn was still sterile.Re-accessed with another power loc mediport without issue.
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 tubing separation was confirmed and the cause appeared to be supplier-related.The product returned for evaluation was one 19ga x 0.75¿ powerloc safety infusion set with y-site.Light usage residues were observed.The proximal extension tubing was completely detached from the y-site.Tactile inspection of the sample did not reveal any tensile weakness.Microscopic inspection of the sample did not reveal any deformation of the tubing or y-site.Inspection under an ultraviolet light revealed fluorescing adhesive residue.The observed detachment was caused by failure of the bond between the proximal extension tubing and the y-site.The lack of tensile weakness or other evidence of mishandling by the user suggested that bond failed do to insufficient adhesive deposition or curing.The device is a supplied component and the supplier has been notified of this event.A lot history review (lhr) of asdrf078 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERLOC SAFETY INFUSION SET 19G X 0.75IN WITH Y-SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10352733
• Report Number: 3006260740-2020-02751
• Device Sequence Number: 16726903
• Product Code: FPA
• UDI-Device Identifier: 00801741047916
• UDI-Public: (01)00801741047916
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

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: 0671934
• Device Lot Number: ASDRF078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Weight: 22