MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD MYPICC KIT POWRPICC SOLO FT SHERLOCK 3CG (5F) (DUAL-LUMEN) (TPS); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	CK000610
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 18gbl521 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the kit was opened on the side seal upon receipt, out of the case.
Event or Problem Description
It was reported that the kit was opened on the side seal upon receipt, out of the case.
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 outer packaging being open is confirmed but the exact cause could not be determined.One bard mypicc kit was returned for investigation with ref: ck000610 and lot: 18gbl521.The outer bag seal was observed to be partially opened.The opened area measured to be 17 cm starting 8.8 cm from the left side of the kit.The presence of material transfer from the seal measured to be 1.2 cm in thickness and was consistent across the open section of the seal.The pouch within the package containing the lidocaine vial appears to be damaged since fluid was observed within the packaging.The kit appears to have been handled with a large force that caused a break in the lidocaine vial and header bag seal.The packaging shows evidence that it was properly sealed, but must have been inadvertently opened and may have occurred outside bd control due to improper handling or storage conditions.

• Brand Name: BARD MYPICC KIT POWRPICC SOLO FT SHERLOCK 3CG (5F) (DUAL-LUMEN) (TPS)
• 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: 8177416
• Report Number: 3006260740-2018-03604
• Device Sequence Number: 16408423
• Product Code: LJS
• UDI-Device Identifier: 00801741121241
• UDI-Public: (01)00801741121241
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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): 01/24/2019

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: CK000610
• Device Catalogue Number: CK000610
• Device Lot Number: 18GBL521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1