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U.S. Department of Health and Human Services


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Catalog Number UNKNOWN
Device Problem Break (1069)
Patient Problems Swelling (2091); Device Embedded In Tissue or Plaque (3165)
Event Date 09/09/2019
Event Type  Injury  
Manufacturer Narrative
Device expiration date: unknown. The customer's address is unknown: (b)(6) usa has been used as a default. Fda notified: the initial reporter also notified the fda on (date) via medwatch # 5091013. Investigation summary: level b investigation complaint evaluation / complaint history check for the event(s) that occurred. Severity: s_3__; occurrence: unable to perform complaint lot history check for needle breaks off during use and harm/infection due to unknown lot number. Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. Complaints received for this device and reported condition will continue to be tracked and trended. If samples are received in the future the complaint will be reopened for further investigation. Unable to perform a dhr review due to an unknown lot number. Investigation conclusion: as no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned. Rationale: based on the investigation, no additional investigation and no capa is required at this time. Device manufacture date: unknown. 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.
Event Description
It was reported that an unspecified number of an unspecified bd syringe experienced cannula breaking off or pulling out during use. The product defect led to a portion of the needle breaking off and embedding itself within the patient's stomach. Patient received x-ray imaging in an effort to locate the broken embedded needle, but was unsuccessful in locating it. Patient then experienced swelling in the abdominal area, and returned to her health care professional. The device was then removed by the health care professional. The following information was provided by the initial reporter: material no: unknown. Batch no: unknown. Verbatim: caller reported syringe needle broke and was entrapped in her stomach. She went to the er and had an x-ray, however the needle could not be visualized. The surgeon informed her to return if there are signs of infection. Caller noticed an infection and inflammation in her abdomen. She returned to the surgeon and had the needle removed on 2019.
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Type of DeviceSYRINGE
Manufacturer (Section D)
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
MDR Report Key9483146
MDR Text Key172711059
Report Number2243072-2019-02836
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/17/2019 Patient Sequence Number: 1