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

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.

Manufacturer Narrative

The following fields have been updated with corrections: pma/510(k)#: k980580.

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 17may2019 via med info.Received a call on 17 may2019 warm transferred from shire ae line, 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.(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.

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 17may2019 via med info.Received a call on (b)(6) 2019 warm transferred from shire ae line, 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.

Manufacturer Narrative

Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.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.

• Brand Name: BD SLIP TIP SYRINGE W/ ATTACHED NEEDLE
• Type of Device: SYRINGE W/ NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8691755
• MDR Text Key: 147862710
• Report Number: 1213809-2019-00612
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903095972
• UDI-Public: 30382903095972
• Combination Product (y/n): N
• PMA/PMN Number: K980580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• 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 Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 309597
• Device Lot Number: 9070752
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other