MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK IV SELECT MACROBORE 6IN IV START KIT 50 BOX; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/21/2020
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 judz0180 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "yesterday afternoon i had a patient's j loop attached to the iv catheter come out from the plastic attachment.It was attached at the site where the stat lock is so the patient couldn't have inadvertently pulled it out".
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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached luer adaptor is confirmed; however, an exact cause could not be determined from the returned photographs.Two photographs of extension sets were returned for evaluation.An initial visual observation of the first photograph showed the distal male luer adaptor of an extension set was missing.The distal end of the tubing appeared to be very flat and clean with distinct edges.A clear liquid was observed within the tubing and a needleless injection cap was observed on the proximal female luer adaptor.The slide clamp and dust cap were observed to be missing and could not be seen in the returned photographs.The second photograph showed another extension set which appears to be unused and undamaged.While the exact cause of the detached luer adaptor could not be determined, possible causes include sharp instrument damage, tensile failure, and poor bond between tubing and luer adaptor.A lot history review (lhr) of judz0180 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "yesterday afternoon i had a patient's j loop attached to the iv catheter come out from the plastic attachment.It was attached at the site where the stat lock is so the patient couldn't have inadvertently pulled it out".
Event or Problem Description
It was reported "yesterday afternoon i had a patient's j loop attached to the iv catheter come out from the plastic attachment.It was attached at the site where the stat lock is so the patient couldn't have inadvertently pulled it out.".
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, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached luer hub is confirmed and was determined to be manufacturing related.One extension set and one open statlock iv start kit were returned for evaluation.An initial visual observation showed use residue on the extension set and the distal luer hub and slide clamp of the extension set was observed to be missing.A handwritten note was returned on the open statlock iv start kit which stated, ¿complete kit to compare with damaged tubing¿ and the extension set within this kit was found to be undamaged.A microscopic observation of the damaged extension set revealed very little adhesive residue on the distal end of the extension set tubing.Striations were observed on the surface of the distal end of the extension set tubing, which was observed to be very straight and flat with slightly flared edges, suggesting this is likely the manufactured end.The evidence observed on the returned sample suggest the distal luer hub became detached from the tubing due to a poor bond between the hub and the tubing.A lot history review (lhr) of judz0180 showed one other similar product complaint(s) from this lot number.

• Brand Name: STATLOCK IV SELECT MACROBORE 6IN IV START KIT 50 BOX
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10050006
• Report Number: 3006260740-2020-01725
• Device Sequence Number: 3292770
• Product Code: FPA
• UDI-Device Identifier: 00801741082665
• UDI-Public: (01)00801741082665
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K942931
• 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,Followup
• Report Date (Section B): 11/24/2020

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: 03/28/2022
• Device Model Number: N/A
• Device Catalogue Number: IVK0177
• Device Lot Number: JUDZ0180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/22/2020
• Supplement Date Received by Manufacturer: 05/13/2020; 10/28/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 06/01/2020; 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 DA
• Patient Weight: 125