MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGROSHONG CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 5F MAXIMAL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	9818508D
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 device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of reas1442 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the catheter broke in half when the patient was adjusting it.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend 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 powergroshong catheter was confirmed; however, the root cause was not identified.The product returned for evaluation was one 5fr powergroshong catheter luer adapter.Usage residues were observed throughout the sample.No catheter tube was returned for evaluation.No catheter fragments were evident in the returned connector/sleeve assembly.The blunt connector, outer sleeve appeared unremarkable.Following removal of the outer sleeve, inspection of the compression sleeve was unremarkable.Microscopic inspection of the connector, compression sleeve and outer sleeve did not reveal any obvious damage or deformity.The catheter was completely detached from the returned connector.No obvious connector component defects were identified.Without the catheter to examine, it could not be determined how the detachment occurred.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include tensile (pulling) stress and improper catheter/connector assembly.A lot history review (lhr) of reas1442 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the catheter broke in half when the patient was adjusting it.

• Brand Name: POWERGROSHONG CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 5F MAXIMAL
• 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: 7675923
• Report Number: 3006260740-2018-01666
• Device Sequence Number: 13841500
• Product Code: LJS
• UDI-Device Identifier: 00801741036095
• UDI-Public: (01)00801741036095
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K063848
• 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): 08/14/2018

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: 9818508D
• Device Catalogue Number: 9818508D
• Device Lot Number: REAS1442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1