MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO 4F SL MAX BARRIER PLUS KIT W/GUARDIVA, PROBE COVER, & BELDAR NEED; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/21/2019
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 recz2861 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the rn went to get the kit off the shelf and when she picked it up, noticed the seal was not intact.The rn did not utilize on a patient.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s) and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of the packaging seal not being intact is confirmed; however, the exact location at which the seal was peeled open and cause remains unknown.One 4 fr sl powerpicc solo catheter kit with lot: recz2861 was returned for investigation.The kit contents were returned outside of the outer packaging.The outer packaging was also returned.The top seal was returned open.Evidence of seal material transfer was present on the clear film.The opposing surface on the tyvek showed a crease which further supports that a complete seal was present.The sealed portion of the packaging was peeled open and no apparent issues were observed or felt.The packaging was observed to have permanent indentations and wrinkling.The width of the seal material transfer present on the top packaging seal was measured and was found to be within specification.Since evidence of a proper seal being applied at the time of manufacturing was observed during investigation of the sample, the exact location and time at which the seal was opened is unknown.No additional complaints were reported for this product lot.A review of the manufacturing records and inspections showed no evidence that the reported event was caused by the manufacturing process.
Event or Problem Description
It was reported the rn went to get the kit off the shelf and when she picked it up, noticed the seal was not intact.The rn did not utilize on a patient.

• Brand Name: POWERPICC SOLO 4F SL MAX BARRIER PLUS KIT W/GUARDIVA, PROBE COVER, & BELDAR NEED
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8818894
• Report Number: 3006260740-2019-02138
• Device Sequence Number: 2484837
• Product Code: LJS
• UDI-Device Identifier: 00801741154997
• UDI-Public: (01)00801741154997
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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: 1194108D3
• Device Lot Number: RECZ2861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1