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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT¿ II SYRINGE

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BECTON DICKINSON, S.A. BD DISCARDIT¿ II SYRINGE Back to Search Results
Catalog Number 309110
Device Problem Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/17/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Investigation summary: bd has been provided with 6 affected samples to investigate for this record. After the analysis of the samples, the high sliding force to glide the plunger rod was very apparent. As a result, bd was able to verify the reported issue of plunger/tip leakage. The reported functionality defect is produced by improper injection in the barrel filling phase. It could occur cause if there is a particle inside the mold that produces stripes in the internal wall of the barrel. In extreme cases, that issue could produce functionality problems during the use of the syringe. Based on our strict inspection plan, the reoccurrence of this issue is very low. Based on an evaluation of severity and occurrence it was determinate that no corrective action is required at this time. Investigation conclusion. Sample evaluation. We have been provided with 6 affected samples. After the analysis of the samples, the high sliding force to glide the plunger rod was very apparent, so we could confirmed the reported issue. Bhr review. We have reviewed our production and inspection records and have established that all production and quality processes were carried out normally. Neither qa nor ncmr's. Syringes were packed in machine (b)(4) (february 21st - 22nd, 2017). Syringes were assembled in machine, (b)(4), in lot #7048467 (february 20th - 27th, 2017). Research has found no problems, defects or qn related to the reported issue. We have also reviewed the barrel lots #7048395, and #7041289 and no problems, defects or qn related to the reported issue were found. We have also reviewed the plunger lots #7048399, and #7041294 and no problems, defects or qn related to the reported issue were found. We have also reviewed the performed sliding test for this lot (march 2nd, 2017), and all values were within specifications. Root cause description. Root cause analysis. The reported functionality defect is produced by improper injection in the barrel filling phase. It could occur cause if there is a particle inside the mold that produces stripes in the internal wall of the barrel. In extreme cases, that issue could produce functionality problems during the use of the syringe. Based on our strict inspection plan, the recurrence of this issue is very low. Confirmation. The returned samples presented high sliding force. We could confirm the reported issue. Capa determination. No - based on an evaluation of severity and occurrence it was determinate that no corrective action is required at this time.
 
Event Description
It was reported that before use a bd discardit¿ ii syringe malfunctioned as"when preparing medication the plunger was hard to move and manipulate. The hcws thought drugs were changing the state of syringes however it seems that the whole batch 1702247 is concerned by this problem, the syringes are hard, almost "crystalized. "there was no report of exposure, injury or medical intervention needed.
 
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Brand NameBD DISCARDIT¿ II SYRINGE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga
Manufacturer (Section G)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7574749
MDR Text Key110591364
Report Number3002682307-2018-00141
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 05/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Catalogue Number309110
Device Lot Number1702247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2017
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: 06/06/2018 Patient Sequence Number: 1
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