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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD MICRO-FINE¿ PEN NEEDLE; INSULIN PEN NEEDLE
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BD (SUZHOU) BD MICRO-FINE¿ PEN NEEDLE; INSULIN PEN NEEDLE Back to Search Results
Catalog Number 329492
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/24/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).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 bd micro-fine¿ pen needle had a broken needle.Furthermore "it has been confirmed by ct scan that the broken needle was in the small intestine".The broken needle was removed via surgery.
 
Manufacturer Narrative
Investigation summary: bd received one sample from the customer in support of this complaint.The returned sample showed the reported defect.Retention samples were checked, cannula quality meet requirement.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.Investigation conclusion: retain sample was checked and all cannula quality meet requirement.Manufacture process perform 100% vision inspection on cannula and do not have quality issue according to dhr review.According to the customer's description, the child struggled during the injection, which could be the possible cause of the broken needle.Based on the investigation above, the complain is not a manufacture issue.
 
Event Description
It was reported that bd micro-fine¿ pen needle had a broken needle.Furthermore "it has been confirmed by ct scan that the broken needle was in the small intestine".The broken needle was removed via surgery.
 
Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: required intervention.Device single use?: no.Device returned to manufacturer: yes.
 
Event Description
It was reported that bd micro-fine¿ pen needle had a broken needle.Furthermore "it has been confirmed by ct scan that the broken needle was in the small intestine".The broken needle was removed via surgery.
 
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Brand Name
BD MICRO-FINE¿ PEN NEEDLE
Type of Device
INSULIN PEN NEEDLE
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
MDR Report Key7695664
MDR Text Key114225420
Report Number3006948883-2018-00113
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 distributor,foreign,other
Type of Report Initial,Followup,Followup
Report Date 08/15/2018
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 No Information
Device Expiration Date06/30/2022
Device Catalogue Number329492
Device Lot Number7188304
Initial Date Manufacturer Received 06/24/2018
Initial Date FDA Received07/17/2018
Supplement Dates Manufacturer Received06/24/2018
06/24/2018
Supplement Dates FDA Received07/27/2018
09/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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