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

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 ascss0073 showed no other similar product complaint(s) from this lot number.(b)(4).
Event or Problem Description
It was reported via medwatch report that the "nurse was preparing to access a port when the power injection infusion set fell apart.The tubing came off at the needle set.The nurse had primed the line with normal saline and was going to access the port.As she picked up the port needle and was about to access the patient, the entire tubing fell into x3 pieces (needle, tubing, and clamp).The needle was never inserted into the patient.".
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), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint that ¿the power injection infusion set fell apart¿ was confirmed and the cause appeared to be supplier-related.The product returned for evaluation was one 19ga x 0.75¿ powerloc max safety infusion set.The housing was completely detached from the extension tubing.The tubing appeared intact.Tactile inspection of the sample did not reveal any tensile weakness.Microscopic inspection of the sample confirmed the tubing to be intact.Inspection using an ultraviolet light revealed no obvious adhesive residue on the tubing.Minimal adhesive residue was observed within the housing orifice.The lack of adhesive residue and lack of tensile weakness suggested that the tubing detachment from the housing was caused by improper/incomplete bonding during device assembly.The device is a supplied component and the supplier has been notified of this event.(b)(4).
Event or Problem Description
It was reported via medwatch report that the "nurse was preparing to access a port when the power injection infusion set fell apart.The tubing came off at the needle set.The nurse had primed the line with normal saline and was going to access the port.As she picked up the port needle and was about to access the patient, the entire tubing fell into x3 pieces (needle, tubing, and clamp).The needle was never inserted into the patient.".

• 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: 8295268
• Report Number: 3006260740-2019-00138
• Device Sequence Number: 18870681
• Product Code: FPA
• UDI-Device Identifier: 00801741047428
• UDI-Public: (01)00801741047428
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019
• Report Date (Section F): 01/09/2019

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: 0141975
• Device Lot Number: ASCSS0073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2019
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1