MAUDE Adverse Event Report: BARD ACCESS SYSTEMS FULL KIT 18G X 10 CM WITH PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reds4456 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the patient reported pain at site with flushing, so midline was removed.Upon pulling the midline out, it was stated only the hub with a very small portion of the catheter came out.Nurse was unable to visualize the catheter.Ir attempted to removed the portion of catheter but was unable.The floor placed a standard iv.
Event or Problem Description
It was reported the patient reported pain at site with flushing, so midline was removed.Upon pulling the midline out, it was stated only the hub with a very small portion of the catheter came out.Nurse was unable to visualize the catheter.Ir attempted to removed the portion of catheter but was unable.The floor placed a standard iv.
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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint that only a portion of the catheter was removed with the hub was inconclusive since the original affected sample was not returned for investigation.Nine 18g x 10cm powerglide catheters were returned for investigation.The catheters were received in sealed packages.The catheters were removed from the kits and no damage or defects were observed on the catheters.A microscopic examination revealed that each catheter shaft was intact.A tactual investigation revealed nothing remarkable.A functional test revealed that each catheter could be removed from the needle without damage.Since the damaged catheter was not returned for investigation, the complaint was inconclusive and the cause of the reported event was undetermined.A lot history review (lhr) of reds4456 showed no other similar product complaint(s) from this lot number.

• Brand Name: FULL KIT 18G X 10 CM WITH PROBE COVER
• 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: 9459485
• Report Number: 3006260740-2019-03833
• Device Sequence Number: 11536016
• Product Code: FOZ
• UDI-Device Identifier: 00801741140617
• UDI-Public: (01)00801741140617
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/06/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F218108PT
• Device Lot Number: REDS4456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 75