MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	0672034J
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/23/2018
Type of Reportable Event	Malfunction
Additional 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) of asbws0126 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the needle protect cover was not attached to the needle from the beginning.No patient involvement.
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 the needle cover not attached is inconclusive due to poor sample condition.One 20 ga x 0.75 in powerloc safety infusion set was returned for investigation.The safety mechanism was not active.No plastic needle cover was returned.The safety mechanism was activated.No punctures were observed on the tyvek or on the clear film packaging.The proximal luer cap was not attached.Saline residue appeared to be visible within the tubing.As no plastic cover was returned with the sample, the complaint of the plastic needle cover not being attached is inconclusive due to poor sample condition.Based on the description of the reported event and condition of the returned sample, possible contributing factors include handling of the device within its packaging and during use.A lot history review (lhr) of asbws0126 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the needle protect cover was not attached to the needle from the beginning.No patient involvement.

• Brand Name: POWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7456334
• Report Number: 3006260740-2018-00800
• Device Sequence Number: 1340294
• Product Code: LJT
• UDI-Device Identifier: 00801741151477
• UDI-Public: (01)00801741151477
• 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,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2018

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 Catalogue Number: 0672034J
• Device Lot Number: ASBWS0126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1