MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 8F SINGLE-LUMEN CV CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF; 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 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 clear plastic sheath on the tip of the dilator was confirmed and was determined to be manufacturing related.One 8fr introducer sheath and dilator were returned for investigation.The returned sample matches the product in the provided photograph.The dilator was received assembled within the sheath.A visual observation of the returned sample revealed that a clear sleeve with a length of 0.5¿ and outside diameter (od) of 0.110¿ was still attached to the distal tip of the dilator.The sleeve had been advanced 8mm over the tip of the dilator.The dimensions of the sleeve match those of the protective tube that should be removed from the dilator when the introducer is packaged into finished kits.A microscopic examination revealed a red colored residue within the sleeve.It was reported that the sleeve was detected as they were preparing to thread the introducer over the wire.A tactual investigation revealed that the sleeve was snug on the tip of the dilator.A lot history review (lhr) of rean1218 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Per sales representative, the facility reported that in prepping the peelaway sheath, the tech noticed a clear plastic sheath over the very tip of the sheath that the facility had never seen there before.It was stated it is about 3/8¿ long and "nearly invisible".The tech said he noticed it as he prepared to thread the sheath on to the wire.It was not used on the patient.

• Brand Name: GROSHONG 8F SINGLE-LUMEN CV CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF
• 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: 6472224
• Report Number: 3006260740-2017-00361
• Device Sequence Number: 19096104
• Product Code: LJS
• UDI-Device Identifier: 00801741036767
• UDI-Public: (01)00801741036767(17)210128(10)REAN1218
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K831386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2017
• Report Date (Section F): 03/15/2017

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: 01/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 7711804
• Device Lot Number: REAN1218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/14/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2017
• Initial Report FDA Received Date: 04/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/15/2017