MAUDE Adverse Event Report: BECTON DICKINSON BD PHASEAL¿ INFUSION CLAMP M25; INTRAVASCULAR CATHETER SECUREMENT DEVICE

Model Number	515085
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.The lot # reported (191001) is not a manufactured lot for this device.The following information is believed to be correct, however, was not able to be confirmed: medical device lot #: 1910001.Medical device expiration date: 2024-09-30.Device manufacture date: 2019-11-07.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the infusion clamps were not functioning with a bd phaseal¿ infusion clamp m25.The following information was provided by the initial reporter: it was reported that the infusion clamps would not click into place or close properly and that the tab would not lock into place.Additionally, the bd sales consultant provided the following additional information: i wanted to report an issue that took place today with several infusion clamps while at emory.Out of 3 boxes of 25, several of them would not "click" into place or close as they should, the small tab that locks the 2 sides together wouldn't lock.Out of 3 boxes, i would guess up to ~ 30% of the samples had this issue.
Event or Problem Description
It was reported that the infusion clamps were not functioning with a bd phaseal¿ infusion clamp m25.The following information was provided by the initial reporter: it was reported that that the infusion clamps would not click into place or close properly and that the tab would not lock into place.Additionally, the bd sales consultant provided the following additional information: i wanted to report an issue that took place today with several infusion clamps while at emory.Out of 3 boxes of 25, several of them would not "click" into place or close as they should, the small tab that locks the 2 sides together wouldn't lock.Out of 3 boxes, i would guess up to ~ 30% of the samples had this issue.
Additional Manufacturer Narrative
Investigation: the final product for lot 1910001 is manufactured at a supplier site.We have notified the supplier of the reported issue and provided samples for evaluation.Functional testing was performed on the samples provided, verifying there were able to be properly closed.A review of lot 1910001 was performed, all samples were 100% inspected for product function and no deviations were identified during the manufacturing of this lot that could contribute to the reported failure.Twenty retained samples of the same lot were used for additional evaluation, all product functioned as intended and we were able to properly close the clamps without issue.Based on the available information we were not able to identify a root cause at this time.
Additional Manufacturer Narrative
After further review, this complaint was determined to not be reportable.If the infusion clamp comes off or is displaced, this may lead to customer dissatisfaction as a new clamp is required but does not lead to any degree of harm/serious injury.Please consider mdr void.
Event or Problem Description
It was reported that the infusion clamps were not functioning with a bd phaseal¿ infusion clamp m25.The following information was provided by the initial reporter: it was reported that the infusion clamps would not click into place or close properly and that the tab would not lock into place.Additionally, the bd sales consultant provided the following additional information: i wanted to report an issue that took place today with several infusion clamps while at emory.Out of 3 boxes of 25, several of them would not "click" into place or close as they should, the small tab that locks the 2 sides together wouldn't lock.Out of 3 boxes, i would guess up to ~ 30% of the samples had this issue.

• Brand Name: BD PHASEAL¿ INFUSION CLAMP M25
• Common Device Name: INTRAVASCULAR CATHETER SECUREMENT DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9539635
• Report Number: 2243072-2019-02935
• Device Sequence Number: 14142255
• Product Code: KMK
• UDI-Device Identifier: 00382905150852
• UDI-Public: 00382905150852
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2022

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: Other
• Device Model Number: 515085
• Device Catalogue Number: 515085
• Device Lot Number: SEE H.10
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 12/18/2019; 05/11/2022
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 04/09/2020; 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown