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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INTERLINK EXT 1 ADAPTER LINE STD BORE; INTERLINK ADAPTER
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BECTON DICKINSON INTERLINK EXT 1 ADAPTER LINE STD BORE; INTERLINK ADAPTER Back to Search Results
Catalog Number A2N3375-ZBA
Device Problem Device Damaged Prior to Use (2284)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2021
Event Type  malfunction  
Manufacturer Narrative
Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.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.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that the interlink ext 1 adapter line std bore experienced a missing end cap.The following information was provided by the initial reporter: the connector cover was detached upon arrival.
 
Manufacturer Narrative
H6: investigation summary the returned product was taken out from the individual packaging, and the chemical liquid outflow side cap was attached.No abnormality was found in the appearance of the actual product or in the wearing condition of the cap on the side where the chemical solution flowed out.No abnormalities related to this event were found in the manufacturing process of the lot.To date, there have been no other similar event reports for the lot.Since 100% of the products were visually inspected before and after the individual packaging process, it is speculated that the cap on the chemical outflow side may have come off due to some influence during product transportation.However, no abnormality was found in the returned product, so the cause could not be identified.See h10.
 
Event Description
It was reported that the interlink ext 1 adapter line std bore experienced a missing end cap.The following information was provided by the initial reporter: the connector cover was detached upon arrival.
 
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Brand Name
INTERLINK EXT 1 ADAPTER LINE STD BORE
Type of Device
INTERLINK ADAPTER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11369994
MDR Text Key250193138
Report Number2243072-2021-00583
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 04/13/2021
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
Device Operator Other
Device Catalogue NumberA2N3375-ZBA
Device Lot NumberSR20A18114
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2021
Initial Date Manufacturer Received 01/28/2021
Initial Date FDA Received02/24/2021
Supplement Dates Manufacturer Received04/13/2021
Supplement Dates FDA Received04/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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