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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA NEEDLE PRECISIONGLIDE 19X1IN; SYRINGE AND NEEDLE

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BECTON DICKINSON IND. CIRURGICAS LTDA NEEDLE PRECISIONGLIDE 19X1IN; SYRINGE AND NEEDLE Back to Search Results
Catalog Number 300029
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/09/2019
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 an unspecified number of needle precisionglide 19x1in experienced foreign matter contamination in the fluid path.The following information was provided by the initial reporter: when opening the package of the 19g x 1 bd needle it was noticed a dirt on the plastic hub.Information received by email on 4/17/2019: the incident was noticed before the use.There was no damage to the patient/health professional.
 
Event Description
It was reported that an unspecified number of needle precisionglide 19x1in experienced foreign matter contamination in the fluid path.The following information was provided by the initial reporter: when opening the package of the 19g x 1 bd needle it was noticed a dirt on the plastic hub.Information received by email on 4/17/2019: the incident was noticed before the use.There was no damage to the patient/health professional.
 
Manufacturer Narrative
Investigation: batch history analysis (dhr), maintenance records and quality notifications were verified, no quality deviations occurred only one maintenance record was detected.We received the picture sent by the client for evaluation, so it was possible to carry out an investigation, confirm the complaint for the defect and determine the probable root cause.The foreign matter occurred due to one machine cleanness packing machine after maintenance.Fm was oil.For this kind of failure one blitz was raised to avoid new occurrences.
 
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Brand Name
NEEDLE PRECISIONGLIDE 19X1IN
Type of Device
SYRINGE AND NEEDLE
Manufacturer (Section D)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
MDR Report Key8557398
MDR Text Key146514871
Report Number3003916417-2019-00214
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
Type of Report Initial,Followup
Report Date 05/23/2019
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
Device Operator Other
Device Expiration Date11/30/2023
Device Catalogue Number300029
Device Lot Number8318695
Initial Date Manufacturer Received 04/10/2019
Initial Date FDA Received04/26/2019
Supplement Dates Manufacturer Received04/10/2019
Supplement Dates FDA Received05/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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