MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 5F MICROEZ UNIVERSAL PTFE MICROINTRODUCER SAFETY KIT; CATHETER INTRODUCER

Model Number	N/A
Health Effect - Clinical Code	No Information (3190)
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 reaw0267 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On (b)(6) 2017- per sales rep, the facility reported that the microintroducer did not completely peel away and a small portion was left around the picc.It was stated that the user had to remove the remaining side of the microintroducer by pulling it away from around the picc with a hemostat.
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, 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 incomplete microintroducer sheath peel was confirmed and the cause appeared to be manufacturing-related.The product returned for evaluation was one 5fr introducer ptfe peel-apart sheath.The sample was received peeled.Blood residue was observed within the sample.The break at the skived region was not regular.More material broke on the left hand tab than on the right hand tab.Microscopic inspection of the excess material on the right hand side revealed material discoloration and deformation.The material exhibited a region of striated texture.The sheath handles failed to split completely along the skiving, resulting in the observed uneven deposition of material along the break surfaces.The failure to split properly appeared to be the result of improper/incomplete skiving during device manufacture.The sample will be forwarded to the manufacturing site for further evaluation.

• Brand Name: 5F MICROEZ UNIVERSAL PTFE MICROINTRODUCER SAFETY KIT
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6353307
• Report Number: 3006260740-2017-00134
• Device Sequence Number: 10772347
• Product Code: DYB
• UDI-Device Identifier: 00801741038389
• UDI-Public: (01)00801741038389(17)201130(10)REAW0267
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K915167
• 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,Followup
• Report Date (Section B): 04/05/2017

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: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 0678950
• Device Lot Number: REAW0267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2017
• Supplement Report FDA Received Date: 04/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1