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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ SLIP TIP SYRINGE W/ ATTACHED NEEDLE SYRINGE W/ NEEDLE

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BECTON DICKINSON MEDICAL SYSTEMS BD¿ SLIP TIP SYRINGE W/ ATTACHED NEEDLE SYRINGE W/ NEEDLE Back to Search Results
Catalog Number 309597
Device Problem Difficult to Remove (1528)
Patient Problem Needle Stick/Puncture (2462)
Event Date 05/17/2019
Event Type  Injury  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that the customer was having a hard time removing the cap from bd¿ slip tip syringe w/ attached needle and had a needle stick injury. The following information was provided by the initial reporter: material no. 309597, batch no. 9070752. It was reported the customer had trouble removing the syringe cap and had a needle stick. An investigation is required. Verbatim: a report was received (b)(6) 2019 via med info. Received a call on (b)(6) 2019, (b)(6), with onboarding access specialist reporting an ae/pqc for gattex. The caller states: i had a call today from a patient who is having problems getting the cap off of the diluent (for gattex) today she said some of the diluent caps are more difficult than others to get off. She reported she had a needle stick as well today. The patient stated her dose today was delayed due to this problem and she will try again later on with other bottles of the diluent she has in her supply. The patient would like more training with this from a nurse and i will be contacting one path to assist with her. The caller states it is unknown if product has been retained by patient for potential return. On (b)(6) 2019- called patient. She reported she actually had trouble removing the syringe cap from the syringe she uses to inject the medicine. She keeps the needle straight and pulls cap off straight. Now uses her thumb to remove cap, so she doesn't jab herself anymore. She reported this to medinfo already. Provided a kit lot number av19094aa and said it happened with a previous kit as well. This record will be updated accordingly and a record for a no lot will be added.
 
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Brand NameBD¿ SLIP TIP SYRINGE W/ ATTACHED NEEDLE
Type of DeviceSYRINGE W/ NEEDLE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8691755
MDR Text Key147862710
Report Number1213809-2019-00612
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980580
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309597
Device Lot Number9070752
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/11/2019
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: 06/12/2019 Patient Sequence Number: 1
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