MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/GUARDIVA AND PROBE COVER; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Codes	Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 reeq0646 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the seal on the kit was opened.It was not used on a patient.
Event or Problem Description
It was reported that the seal on the kit was opened.It was not used on a 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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of open kit seal is confirmed; however, the exact cause is unknown.One 3 fr single lumen provena midline catheter kit was returned for evaluation.An initial visual observation showed the top edge of the kit was returned open; this opening in the packaging was observed to be on the top edge of the tyvek instead of the lower edge of the tyvek, which is the location where the packaging is intended to be open.A solid, unbroken band of seal transfer residue could be seen on the entire length of the clear film of the opening in the packaging.The lidocaine vial and all three chloraprep devices within the kit were found to be broken and empty.The kit tray was observed to have been crushed near its center, apparently from beneath.The damage to the kit tray and the glass components within the kit suggest the opening in the kit packaging was most-likely caused by a sudden, forceful impact which also caused the packaging to burst along its sealed upper edge.However, it was not possible to determine when or where the kit experienced such an impact.This damage could have occurred during transit, handling, or storage.No evidence was found to suggest the kit was not properly sealed prior to when this damage occurred.

• Brand Name: 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/GUARDIVA AND PROBE COVER
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10491536
• Report Number: 3006260740-2020-03160
• Device Sequence Number: 11543282
• Product Code: PND
• UDI-Device Identifier: 00801741154027
• UDI-Public: (01)00801741154027
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2020

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 Expiration Date: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: S4153108DGP
• Device Lot Number: REEQ0646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 12/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1