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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE; PISTON SYRINGE Back to Search Results
Model Number 305269
Device Problem Complete Blockage (1094)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/12/2020
Event Type  malfunction  
Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7208640, medical device expiration date: 2022-07-31, device manufacture date: 2017-07-27.Medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that 1 bd integra¿ syringe with detachable needle from lot# 7208640, and 1 needle from an unspecified lot, were blocked during use.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "customer called and stated that they had 3 separate instances with this product, but she only has the lot for 1, and is not sure if the other needles were part of the same lot.Customer stated that in the first instance, the needle fell out of the syringe and medication went all over the place.In the second instance, when the nurse tried to give the vaccine, the med would not push through.The third instance, the medication would not push through the needle.The only date of event that was given was for the third incident, (b)(6) 2020.".
 
Manufacturer Narrative
Correction: h.6.Investigation summary: two 3ml integra syringes were received and evaluated.One syringe was loose, and one was in an opened blister pack from batch 7208640 (p/n 305269).Both syringes appeared to be manipulated as one syringe contained clear liquid droplets and one syringe had dried white particles inside.Both syringes also had the needle retracted with the cannula concealed inside as expected.No defects could be confirmed.A physical unused sample from the same batch would be helpful to examine if the cannulas were clogged prior to being used.The reported defect could not be identified in the samples received.Both samples were manipulated with the cannulas retracted.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h.10.
 
Event Description
It was reported that 1 bd integra¿ syringe with detachable needle from lot# 7208640, and 1 needle from an unspecified lot, were blocked during use.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "customer called and stated that they had 3 separate instances with this product, but she only has the lot for 1, and is not sure if the other needles were part of the same lot.Customer stated that in the first instance, the needle fell out of the syringe and medication went all over the place.In the second instance, when the nurse tried to give the vaccine, the med would not push through.The third instance, the medication would not push through the needle.The only date of event that was given was for the third incident- (b)(6) 2020.".
 
Manufacturer Narrative
H.6.Investigation summary three 3ml integra syringes were received and evaluated.One syringe was loose and two were in opened blister packs (p/n 305270) with one from batch 7208640 and one from batch 9325616.All three of the syringes appeared to be manipulated as two of the syringes contained clear liquid droplets and one of the syringes had dried white particles inside.Two of the syringes also had the needle retracted with the cannula concealed inside as expected.One of the syringed was observed to have a large plastic flashing present inside the fluid path and was rejectable per product specification.The barrel was from mold c-251 cavity 52.No defects could be confirmed with the other two syringes.A physical unused sample from the same batch would be helpful the examine if the cannula was clogged prior to being used.Potential root cause for the flashing defect is associated with the molding process.No corrective actions are necessary based on the defective rate identified.Batch 9325616 is considered in compliance with our product specification requirements.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.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.
 
Event Description
It was reported that 1 bd integra¿ syringe with detachable needle from lot# 7208640, and 1 needle from an unspecified lot, were blocked during use.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "customer called and stated that they had 3 separate instances with this product, but she only has the lot for 1, and is not sure if the other needles were part of the same lot.Customer stated that in the first instance, the needle fell out of the syringe and medication went all over the place.In the second instance, when the nurse tried to give the vaccine, the med would not push through.The third instance, the medication would not push through the needle.The only date of event that was given was for the third incident- (b)(6) 2020.".
 
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Brand Name
BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key10112522
MDR Text Key200990127
Report Number1213809-2020-00361
Device Sequence Number1
Product Code MEG
UDI-Device Identifier30382903052692
UDI-Public30382903052692
Combination Product (y/n)N
PMA/PMN Number
K011103
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup,Followup
Report Date 06/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number305269
Device Catalogue Number305269
Device Lot NumberSEE SECTION H.10.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/29/2020
Date Manufacturer Received05/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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