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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD MICROLANCE¿ 3 HYPODERMIC NEEDLE; SYRINGE WITH NEEDLE
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BECTON DICKINSON, S.A. BD MICROLANCE¿ 3 HYPODERMIC NEEDLE; SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 301155
Device Problems Fluid/Blood Leak (1250); Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that before use of the bd microlance¿ 3 hypodermic needle there was an issue with connecting the microlance.The connection problem caused leaks during the procedures and required changing the unit three times.
 
Event Description
It was reported that before use of the bd microlance¿ 3 hypodermic needle there was an issue with connecting the microlance.The connection problem caused leaks during the procedures and required changing the unit three times.
 
Manufacturer Narrative
Investigation summary: no samples or photos were returned for investigation.Complaint trending review reveals this is the first complaint for this lot for this defect.Dhr review shows our production and inspection records and have established that all production and quality processes were carried out normally.Neither qn nor ncmr's.Needles were packed in machine 2104 (b)(6) 2017) during which 68 visual inspections were carried out with zero defects noted.Needle were assembled in machine 4411 and come from two batches: #7310580: (b)(6) 2017) 285 visual inspection of 25 units each were performed with zero defects noted.#7186359: (b)(6) 2017) 76 visual inspection of 25 units each were performed with zero defects noted.Research has not found any abnormality in injected hub batches #7187497 and #7193229 (mold machine #3583, (b)(6)2017).3 qn (#10159, #9502 and #9635) related to flashes were reached in injected hub batches #7297691, #728245 and #9635, respectively; 4 qn (b)(4) related to burnt resin was reached in injected hub batches #728245, #7296015, #7251011 and #7269096; 1 qn (b)(4) related to chipped pin in injected hub batch #7282445, but these would affect whether or not the reported connection problem.Root cause description: since bd was unable to duplicate your indicated failure mode because no sample or pictures has been provided and review of dhr show no abnormalities during needles manufacturing, a definitive root cause related needle manufacturing process is not possible to determine, at this time.The defective connectivity may be because of a defective luer dimensions or any damage in the syringe tip, but it could be also related with the handling of the product as some insufficient adjustment between of the devices by the end user.On the other hand, bd is certain that the probability of having some damaged needle causing detached in our product is very low based on the preventive measures, absence of complaints of other customers and our sampling inspection plan.Rationale: since complaint is not possible to confirm because no sample or picture has been provided and review of dhr reveal no abnormalities and in compliance with specification, it was determine that no corrective actions are required at this time.
 
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Brand Name
BD MICROLANCE¿ 3 HYPODERMIC NEEDLE
Type of Device
SYRINGE WITH NEEDLE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga
MDR Report Key8155937
MDR Text Key130328767
Report Number3002682307-2018-00304
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
N/A
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 01/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2022
Device Catalogue Number301155
Device Lot Number171126
Date Manufacturer Received11/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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