MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 7 FR. PTFE PEEL-APART PERCUTANEOUS INTRODUCER KIT; CATHETER INTRODUCER

Model Number	0601170
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); Foreign Body In Patient (2687)
Date of Event	05/29/2017
Type of Reportable Event	Serious Injury
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 reaz1304 showed one other similar product complaint(s) from this lot number.Both complaints for this lot number (reaz1304 have been reported from the same (b)(4) facility.
Event or Problem Description
It was reported the clavicular bone was punctured and while manipulating the needle, one part got stuck in the patient.The needle broke into two pieces.There were no problems removing the broken part from the patient.
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 broken needle shaft was confirmed and the cause was determined to be use related.The product returned for evaluation was a 19ga x 2.72¿ introducer needle shaft.The associated luer connector was not returned.Gross visual examination of the needle confirmed a complete break of the shaft at the proximal end.The needle tube was compressed into an elliptical shape and was hooked at the break site.Microscopic examination revealed the presence of wrinkled markings near the inside edge of the hooked break site.Sharp-cornered kink points were seen at circumferentially opposite ends of the break site and the fracture surface was granular.No potential manufacture damage, defect, or deformity was observed and the sample was measured to be within specification.The observed damage was characteristic of bending the needle to the point of failure.It was stated in the event description that the clavicular bone was punctured and ¿while manipulating the needle, one part got stuck in the patient¿.The evidence suggests that this manipulation included forceful bending of the needle which ultimately broke the needle shaft.No evidence was observed to suggest that the needle was otherwise damaged or manufactured outside of intended design.
Event or Problem Description
It was reported the clavicular bone was punctured and while manipulating the needle, one part got stuck in the patient.The needle broke into two pieces.There were no problems removing the broken part from the patient.

• Brand Name: 7 FR. PTFE PEEL-APART PERCUTANEOUS INTRODUCER KIT
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6656645
• Report Number: 3006260740-2017-00874
• Device Sequence Number: 1541322
• Product Code: DYB
• UDI-Device Identifier: 00801741038327
• UDI-Public: (01)00801741038327(17)211231(10)REAZ1304
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K860432
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 0601170
• Device Catalogue Number: 0601170
• Device Lot Number: REAZ1304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 07/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1