MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH, 22 GX1.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	AC0221250
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 be evaluated.Results are expected soon.A lot history review (lhr) of rebt1445 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that the metal (needle) was "weak" after insertion and flash using ultrasound guidance.It was stated that it almost broke off in the patient.
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 bent needle was confirmed, and it appeared that the damage occurred during use of the product.One accucath deployment system was returned for investigation.The needle was extending from the deployment system.The guidewire slider was positioned at the proximal end of the handle.The accucath catheter had been removed from the needle and was not returned for investigation.Blood residue was observed in the chamber, which indicates that the sample was used.The needle was bent at the flash port.Due to the condition of the returned sample, it appeared that the needle was bent during use.Since the product was within specification, it appeared the needle was subject to bending stresses that exceeded its strength.The accucath ifu states, ¿do not bend the needle before or during use as this may affect proper needle retraction.¿ a lot history review (lhr) of rebt1445 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that the metal (needle) was "weak" after insertion and flash using ultrasound guidance.It was stated that it almost broke off in the patient.

• Brand Name: ACCUCATH, 22 GX1.25
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6818945
• Report Number: 3006260740-2017-01439
• Device Sequence Number: 67896
• Product Code: FOZ
• UDI-Device Identifier: 00801741110924
• UDI-Public: (01)00801741110924
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K153298
• 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): 09/21/2017

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: 05/31/2018
• Device Model Number: AC0221250
• Device Catalogue Number: AC0221250
• Device Lot Number: REBT1445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 08/24/2017
• Supplement Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1