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
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2019
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 ascps0155 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the needle of power lock was accessed to the port body of power-port and medication was administered on (b)(6) 2019.Because the medicine was difficult to infuse, the contrasut examination was performed after completion fo the medication.However, there was no leakage nor damage found by ct.After the flushing, medication had not done for six days though the needle was left to access to the port body.It was further reported that when flush was conducted before starting medication on (b)(6) 2019, the leakage was found near the connection between the hub of the needle and the syringe.There was no reported patient injury.
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 a leak is confirmed; however, the exact cause is unknown.One 19 g x 0.75 in.Powerloc with a y-site was returned for evaluation.An initial visual observation showed use residue throughout the returned sample.The sample was flushed with a 12 ml syringe of water and a spraying leak was observed emanating from the luer connector hub.A microscopic observation revealed a large, straight, longitudinal crack in the luer connector hub.The crack was observed to begin at the proximal end of the hub and extend into the wing of the hub.While the exact cause of the crack in the luer connector hub is unknown, possible contributing factors include forceful insertion of a tapered object into the orifice of the luer hub and over-tightening of the connector.A lot history review (lhr) of ascps0155 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the needle of power lock was accessed to the port body of powerport and medication was administered on (b)(6) 2019.Because the medicine was difficult to infuse, the contrasut examination was performed after completion fo the medication.However, there was no leakage nor damage found by ct.After the flushing, medication had not done for six days though the needle was left to access to the port body.It was further reported that when flush was conducted before starting medication on (b)(6) 2019, the leakage was found near the connection between the hub of the needle and the sylinge.There was no reported patient injury.

• 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: 8340929
• Report Number: 3006260740-2019-00255
• Device Sequence Number: 2229672
• Product Code: LJT
• UDI-Device Identifier: 00801741151453
• UDI-Public: (01)00801741151453
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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: 0671934J
• Device Lot Number: ASCPS0155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1