MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BASIC KIT 20G X 8 CM WITH GUARDIVA; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAY

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of rees1400 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the safety of the needle got stuck in the stopper, left tip of needle exposed.Additional information received 7/29/2020: picc was placed in the left basilic.The safety got stuck in the tip reservoir when the needle was withdrawn, leaving an exposed sharp/tip of the needle.There was no harm to the patient, but an increased risk to the user.The midline was placed otherwise fine.
Event or Problem Description
It was reported the safety of the needle got stuck in the stopper, left tip of needle exposed.Additional information received 7/29/2020: picc was placed in the left basilic.The safety got stuck in the tip reservoir when the needle was withdrawn, leaving an exposed sharp/tip of the needle.There was no harm to the patient, but an increased risk to the user.The midline was placed otherwise fine.
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of safety mechanism failure was confirmed; however, the root cause was not identified.The product returned for evaluation was one 20ga x 8cm powerglide pro midline catheter assembly safety cannister.The cannister was received completely detached from the needle shaft.The remaining assembly, including the needle shaft was not returned for evaluation.The detached safety cannister was full of blood residue.Following disassembly of the safety, inspection of the red o-ring ring revealed a complete break.Microscopic inspection of the ring confirmed a complete break.The fracture surface was sharply defined and exhibited a granular fracture surface.Inspection of the binding clip revealed it to appear well-formed.The edge-breaking appeared complete throughout the interface region with the ring.While the safety mechanism was confirmed to be detached from the needle shaft, it could not be determined if the safety failed because the ring was already damaged or if the ring was damaged during the same event that caused the safety to become detached.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include excessive force during safety activation and retention ring damage during safety mechanism assembly.A lot history review (lhr) of rees1400 showed no other similar product complaint(s) from this lot number.

• Brand Name: BASIC KIT 20G X 8 CM WITH GUARDIVA
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAY
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10405315
• Report Number: 3006260740-2020-02936
• Device Sequence Number: 2991909
• Product Code: FOZ
• UDI-Device Identifier: 00801741140471
• UDI-Public: (01)00801741140471
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2020

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: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: F120087T
• Device Lot Number: REES1400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 10/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR