MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD MYPICC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	CK000310A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of 18ob3999 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a picc line appeared frayed, it was kinked and "caused some issues for a patient." no additional information was reported.
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 a damaged microintroducer is confirmed to be use related.One 4.5 microintroducer was returned for investigation.The microintroducer was observed to be peeled.An even peel appeared to have occurred between the orange tabs.Use residue was observed.The distal tip was observed to be deformed.Microscopic observation of the tip of the microintroducer in comparison with a non-complainant sample revealed similar characteristics of the form of the distal end.Crimpling of the grey sheath was present near the distal end of the microintroducer.This is indicative of the sheath being advanced against resistance.The ifu states, ¿caution: do not use excessive force when introducing guidewire or microintroducer as this can lead to vessel perforation and bleeding¿ and ¿advance the microintroducer assembly over the guidewire.Using a twisting motion, advance the assembly into the vessel.If necessary, a small incision may be made adjacent to the guidewire to facilitate insertion of the sheath and dilator.¿ based on the condition of the returned sample, possible contributing factors include advancement of the microintroducer against resistance and rough transition.As no indications of a manufacturing related issue being a contributing factor was present, the complaint is confirmed to be use related.A lot history review (lhr) of 18ob3999 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a picc line appeared frayed, it was kinked and "caused some issues for a patient." no additional information was reported.

• Brand Name: BARD MYPICC KIT
• 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: 7793148
• Report Number: 3006260740-2018-02111
• Device Sequence Number: 19132130
• Product Code: LJS
• UDI-Device Identifier: 00801741102639
• UDI-Public: (01)00801741102639
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2018

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 Model Number: CK000310A
• Device Catalogue Number: CK000310A
• Device Lot Number: 18OB3999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1