MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 20G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2020
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 asdtf102 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the patient was being assisted out of bed when the huber needle snapped off below the cap.It was stated there was a slight tug while getting the patient out of bed.They were able to immediately deaccess the patient and then reaccess the port.
Event or Problem Description
It was reported that the patient was being assisted out of bed when the huber needle snapped off below the cap.It was stated there was a slight tug while getting the patient out of bed.They were able to immediately deaccess the patient and then reaccess the port.
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 damaged infusion set was confirmed and the cause was supplier-related.The product returned for evaluation was one 20ga x 1¿ powerloc safety infusion set and one addition luer adapter.The intact device appeared unused and unremarkable.The detached luer adapter was completely detached from the non-returned extension tubing.No tubing material remained within the luer connector distal bore.Usage residues were observed on the detached luer.Microscopic inspection of the detached luer confirmed that no tubing material remained within the bore.Inspection under a uv light revealed incorrectly applied adhesive.The observed luer detachment appeared to be caused by improper/incomplete adhesive application during device assembly.The supplier has been notified of this event.A lot history review (lhr) review is not possible; the manufacturing lot number that was provided is incorrect for the product returned.

• Brand Name: POWERLOC SAFETY INFUSION SET 20G X 1 IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9823416
• Report Number: 3006260740-2020-00821
• Device Sequence Number: 3129876
• Product Code: FPA
• UDI-Device Identifier: 00801741047749
• UDI-Public: (01)00801741047749
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

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: 0652010
• Device Lot Number: ASDTF_102 (INCORRECT/P)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1