MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN 9.6 FR SINGLE-LUMEN CV CATHETER, CUTDOWN TRAY WITH SURECUFF TISSUE INGRO; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
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 huzj1368 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Facility reports the cuff fell off the catheter during catheter insertion.No other information was provided.No harm to the patient 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 detached tissue ingrowth cuff was confirmed; however, the root cause was not identified.The product returned for evaluation was one 9.6fr s/l hickman chronic catheter.The sample appeared free of obvious usage residues.The tissue ingrowth cuff was detached and was not returned for evaluation.Microscopic inspection of the sample revealed adhesive residue at the site of the detachment.The adhesive appeared continuous around the circumference of the catheter.No gaps or voids were observed in the adhesive coverage.Tactile inspection of the sample revealed severe tensile weakness in the vicinity of the site of the cuff detachment.During manufacture, adhesive is applied to the cuff, not to the catheter tubing.Therefore, the presence of continuous adhesive residue on the catheter tubing suggested that the cuff was initially adhered to the catheter during device manufacture and subsequently became detached.The severity of the tensile weakness indicated that device manipulation likely contributed to that detachment.It could not be determined when or how that manipulation occurred, nor to what extent such manipulation contributed.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include cuff manipulation prior to or during attempted use.
Event or Problem Description
It was reported the cuff fell off.Additional information: facility reports the cuff fell off the catheter during catheter insertion.

• Brand Name: HICKMAN 9.6 FR SINGLE-LUMEN CV CATHETER, CUTDOWN TRAY WITH SURECUFF TISSUE INGRO
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6679178
• Report Number: 3006260740-2017-00942
• Device Sequence Number: 13718935
• Product Code: LJS
• UDI-Device Identifier: 00801741051722
• UDI-Public: (01)00801741051722
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2017

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: 10/20/2020
• Device Model Number: N/A
• Device Catalogue Number: 0600160
• Device Lot Number: HUZJ1368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/28/2017
• Supplement Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 07/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1