MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PPICC 5F DL 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of 19uba073 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
It was reported that health professional was inserting a picc and the introducer split when inserting it over the guidewire.They did nick the skin first.No other information was provided.
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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a damaged introducer was confirmed and based on the condition of the returned sample, it appeared that the introducer was damaged during use.One 5fr ptfe introducer sheath was returned for investigation.Damage was observed at the distal end of the sheath.The distal edge of the sheath was crumpled at two points.The undamaged section of the taper at the distal end of the sheath appeared to be properly formed.Residue was observed within the distal end of the sheath, which indicates that the sample was used.This type of damage can occur during use when the sheath comes in contact with the surrounding tissue of the insertion site.The sheath and dilator should be advanced together as a unit over the guidewire, using a slight rotational motion.Since the damage was observed on the sheath, the complaint was confirmed.Due to the condition of the sample, it appeared that the damage occurred during use.A lot history review (lhr) of 19uba073 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
It was reported that health professional was inserting a picc and the introducer split when inserting it over the guidewire.They did nick the skin first.No other information was provided.

• Brand Name: DOT PPICC 5F DL 3CG
• 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: 9861895
• Report Number: 3006260740-2020-00969
• Device Sequence Number: 14310629
• Product Code: LJS
• UDI-Device Identifier: 00801741155284
• UDI-Public: (01)00801741155284
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2020

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 Model Number: N/A
• Device Catalogue Number: CK000852
• Device Lot Number: 19UBA073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1